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Heart Failure clinical trials at University of California Health

48 in progress, 25 open to eligible people

Showing trials for
  • Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

    open to eligible people ages 18 years and up

    This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

    at UC Irvine

  • Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)

    open to eligible people ages 18-85

    This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

    at UC Irvine UCLA

  • CCM in HF With Higher Ejection Fraction

    open to eligible people ages 18 years and up

    The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤60%.

    at UC Davis UCSD UCSF

  • AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

    open to eligible people ages 18 years and up

    Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

    at UCSD UCSF

  • Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

    open to eligible people ages 21 years and up

    Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy. Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.

    at UCSF

  • DORAYA-HF Early Feasibility Study

    open to eligible people ages 18 years and up

    The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.

    at UCSF

  • Early Feasibility Study - Transcatheter Atrial Shunt System

    open to eligible people ages 18 years and up

    The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.

    at UCSD UCSF

  • Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)

    open to eligible people ages up to 17 years

    This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16. The primary hypothesis is Vericiguat is superior to placebo in reducing NT-proBNP at Week 16.

    at UCLA

  • Heart Failure Polypill at a Safety Net Hospital

    open to eligible people ages 18 years and up

    A novel four-drug regimen for heart failure with reduced ejection fraction (HFrEF) extends patients' life expectancy by an average of 6 years compared to traditional therapies, in addition to improving quality of life. Unfortunately, uptake of this complex multi-drug regimen has been low, especially among underserved communities with barriers to medication adherence. Although combination tablets have transformed access to care for conditions such as HIV and tuberculosis, no combination pill is available for HFrEF. In the proposed study, the investigators will utilize inexpensive over-encapsulation techniques to develop a novel combination pill ("polypill") for patients with HFrEF. In Aim 1, the investigators will conduct stakeholder interviews with patients, providers, and pharmacists to inform the design of a HFrEF polypill. In Aim 2, the investigators will conduct a pilot, single-center, crossover randomized clinical trial to investigate whether, compared to usual care, a HFrEF polypill increases medication adherence among 20-40 adults with HFrEF. Given the high daily pill burden among patients with HIV and HFrEF, the investigators aim to recruit a subgroup of patients with HIV (~10-20 participants) in addition to a subgroup of patients without HIV (~10-20 participants).

    at UCSF

  • LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

    open to eligible people ages 18-85

    This study will evaluate the efficacy of TNX-103 (levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).

    at UC Davis UC Irvine UCSF

  • MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation

    open to eligible people ages 18 years and up

    Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.

    at UCSF

  • Metformin for Pulmonary Hypertension HFpEF

    open to eligible people ages 18 years and up

    The main objective of this study is to determine the clinical efficacy of metformin versus placebo and the therapeutic response with regards to functional capacity and hemodynamics in PH-HFpEF.

    at UCSF

  • Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction

    open to eligible people ages 18-80

    It is believed that targeted SERCA2a enzyme replacement in HFrEF patients will correct defective intracellular Ca2+ hemostasis, resulting in improved cardiac contractile function and energetics which will, in turn, translate to improved clinical outcomes. Additionally, it is hypothesized that correcting SERCA2a dysfunction will also improve coronary blood flow through correction of the impaired endothelium-dependent nitric oxide-mediated vasodilatation observed in heart failure.

    at UCSF

  • TRISCEND II Pivotal Trial

    “Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!”

    open to eligible people ages 18 years and up

    Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

    at UC Davis UCSF

  • Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants

    open to all eligible people

    Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward.

    at UC Davis

  • Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure

    open to eligible people ages 18 years and up

    This is a Phase 2 adaptive, double-blinded, placebo-controlled, randomized, multi-center trial study to evaluate the safety and efficacy of a single dose of AB-1002, administered via antegrade intracoronary artery infusion, in males and females age >18 years with non-ischemic cardiomyopathy and NYHA Class III symptoms of HF. Subjects will be randomized into one of three treatment groups in a 1:1:1

    at UCSD

  • Remote Dielectric Sensing (ReDS) Assisted Diuresis in Acute Decompensated Heart Failure

    open to eligible people ages 18 years and up

    This study evaluates the use of a wearable vest capable of non-invasively measuring lung fluid content in hospitalized patients with heart failure

    at UCSF

  • Heart Failure Precision Medicine Study

    open to eligible people ages 21 years and up

    The study aims to test the hypothesis that multi-omics studies can identify Heart Failure profiles at risk of adverse outcomes and evaluate a telemonitoring intervention in the optimization of guideline-directed medical therapy.

    at UC Davis

  • EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

    open to eligible people ages 18 years and up

    The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).

    at UCLA UCSF

  • Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

    open to eligible people ages 18 years and up

    The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.

    at UCSF

  • XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)

    open to eligible people ages 18 years and up

    The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.

    at UCLA UCSD

  • INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM

    open to eligible people ages 22 years and up

    Study Design: This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system.

    at UCSD UCSF

  • Cancer Therapy Effects on the Heart

    open to eligible people ages 13-39

    Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity. Over the long term, children who receive these therapies have an increased risk of heart failure and early cardiovascular death. However, current strategies for identifying patients who are at risk prior to the development of significant changes in heart function are limited. This study will focus on imaging markers of cardiac injury and dysfunction with the goal of developing improved diagnostic tests and treatment strategies.

    at UCSD

  • HeartShare: Combining Omics, Deep Phenotyping, and Electronic Health Records for Heart Failure Subtypes and Treatment Targets

    open to eligible people ages 30 years and up

    HeartShare is a comprehensive study of heart failure, a common and serious medical condition which occurs when the heart is unable to keep up with the demands of the body, resulting in shortness of breath, fluid retention, and fatigue. HeartShare aims to better classify heart failure into subtypes to help develop more personalized treatments for patients, with the hope that this will improve the lives of heart failure patients. To do this, HeartShare is bringing together a large amount of data (including images, such as heart ultrasounds and MRIs and molecular data from the blood, such as genetics) from previously conducted studies and electronic health records, and is gathering new data through participants enrolled in the HeartShare Deep Phenotyping Study.

    at UC Davis

  • Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

    open to eligible people ages 0-20

    The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

    at UCLA

  • Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation

    Sorry, not currently recruiting here

    The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.

    at UC Irvine

  • Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS

    Sorry, in progress, not accepting new patients

    The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe functional mitral regurgitation. Approximately 610 subjects will be randomized at up to 100 investigational sites with approximately 305 subjects targeted to receive the study device. COAPT study completed recruiting subjects in June 2017. As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group) compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study subjects will contribute to the analyses of the COAPT primary and secondary endpoints) As an extension of the COAPT RCT trial, COAPT CAS study will be conducted after COAPT enrollment is complete under the same investigational device exemption (IDE(G120024)). The objective of this study is to evaluate the MitraClip® NT System for the treatment of clinically significant functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. The anticipated Study Completion Date is July 2024. COAPT CAS completed recruiting subjects in March 2019.

    at UC Davis

  • Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial

    Sorry, in progress, not accepting new patients

    The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.

    at UCLA UCSD

  • Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.

    at UCLA

  • Alleviant ALLAY-HF Study

    Sorry, accepting new patients by invitation only

    Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.

    at UCSF

  • Baroreflex Activation Therapy for Heart Failure

    Sorry, in progress, not accepting new patients

    The purpose of this clinical trial (NCT02627196) is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy with the BAROSTIM NEO System in subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III, left ventricular ejection fraction (LVEF) ≤ 35% and NT-proBNP<1600 pg/ml despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT). The total trial duration is anticipated to be approximately 5 years; however, the duration of an individual subject enrollment will depend on when he or she entered the trial.

    at UC Irvine UCSF

  • Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients

    Sorry, in progress, not accepting new patients

    Patients in end-stage cardiac failure and/or respiratory failure may be started on a rescue therapy known as Extracorporeal Membrane Oxygenation (ECMO). One of the major clinical questions is how to manage the ventilator when patients are on ECMO therapy. Ventilator Induced Lung Injury (VILI) can result from aggressive ventilation of the lung during critical illness. VILI and lung injury such as Acute Respiratory Distress Syndrome (ARDS) can further increase the total body inflammation and stress, this is known as biotrauma. Biotrauma is one of the mechanisms that causes multi-organ failure in critically ill patients. One advantage of ECMO is the ability to greatly reduce the use of the ventilator and thus VILI by taking control of the patient's oxygenation and acid-base status. By minimizing VILI during ECMO we can reduce biotrauma and thus multi-organ failure. Since the optimal ventilator settings for ECMO patients are not known, we plan to study the impact of different ventilator settings during ECMO on patient's physiology and biomarkers of inflammation and injury.

    at UCSD

  • Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients

    Sorry, in progress, not accepting new patients

    This study is a prospective, multi-center, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.

    at UCSD

  • Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors

    Sorry, in progress, not accepting new patients

    This phase IIb trial studies how well low-dose carvedilol works in preventing heart failure in cancer survivors exposed to high dose anthracyclines for management of childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much greater risk for developing heart failure compared to survivors who didn't get any anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened and can't pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular complications.

    at UC Davis UCLA

  • DASH Diet in Heart Failure Outpatients

    “Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!”

    Sorry, in progress, not accepting new patients

    The purpose of this study is to refine the classification of the effectiveness of the DASH diet for outpatient heart failure (HF) management, using behavioral, clinical, and laboratory correlative science approaches.

    at UC Davis

  • Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction

    Sorry, in progress, not accepting new patients

    This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).

    at UCSF

  • Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation

    Sorry, in progress, not accepting new patients

    This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation.

    at UCSF

  • Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF

    Sorry, in progress, not accepting new patients

    This is a Phase 2A, randomized, parallel-group, placebo-controlled, double-blind, within subject dose escalation trial with 3 dose levels of HU6 and placebo. Subjects will be randomized (1:1) either to HU6 or placebo. Two dose levels will be administered in sequential order (150 mg daily followed by 300 mg daily), each for 20 days, to reach the third and highest dose of 450 mg daily if safety and tolerability are demonstrated at the lower 2 preceding doses. Administration of the 450 mg high dose will continue for a total of 94 days, with a safety follow-up visit within ~14 days of the last dose.

    at UCLA

  • LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.

    at UC Irvine

  • PROACTIVE-HF IDE Trial Heart Failure NYHA Class III

    Sorry, in progress, not accepting new patients

    This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).

    at UCSD UCSF

  • PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III

    Sorry, not currently recruiting here

    This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial). The study contains of 5 arms: Randomized Arm - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients. - Treatment Arm (Cohort 1) - Active Control Arm (Cohort 2) - Crossover Arm (Cohort 3) Single Arm - To demonstrate safety and efficacy of the Cordella PA Sensor System linked with a clinician-directed patient self-management strategy in NYHA Class III HF patients. - Clinician-Directed Patient Self-Management Arm (Cohort 4) - Clinician Management Arm (Cohort 5)

    at UCSF

  • Reducing Lung CongestIon Symptoms in Advanced Heart Failure

    Sorry, in progress, not accepting new patients

    The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

    at UCLA UCSF

  • AT-001 in Patients With Diabetic Cardiomyopathy

    Sorry, in progress, not accepting new patients

    This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.

    at UC Irvine UCLA UCSD

  • Fontan Dapagliflozin Pilot Study

    Sorry, accepting new patients by invitation only

    The goal of this clinical trial is to study if an investigational study drug called Dapagliflozin could prevent heart failure from getting worse in adults with Fontan circulation. The main questions it aims to answer are: 1. Does Dapagliflozin decrease Fontan pressure? 2. Does Dapagliflozin improve exercise capacity and heart failure symptoms? Participants will have 4 study visits and 2 follow-up phone calls. The total duration of participation in the study will be up to 5 weeks from the time of screening to the completion of the final safety evaluation. Study procedures include the collection of study-related health information and blood samples, physical examination, exercise testing, total body water assessment, blood laboratory testing, health status survey, safety evaluation phone calls, and home blood pressure monitoring.

    at UCLA

  • Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

    Sorry, in progress, not accepting new patients

    The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.

    at UCLA UCSD UCSF

  • Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia

    Sorry, in progress, not accepting new patients

    The CARE-HK in HF is a registry study based on the hypothesis that adherence to guidelines is associated with improved real-world outcomes for heart failure (HF) patients. For the purpose of this study, adherence to guidelines is defined as adherence to RAASi treatment recommendations, according to the AHA/ACC and ESC guidelines. Objectives relating to patiromer effectiveness will only be evaluated if a sufficient number of patients are available. The study aims to evaluate in patients at high risk of hyperkalaemia; patients treated with ACEi/ARB/ARNi, and either treated with or candidates for treatment with MRA.

    at UCSD

  • Destination Therapy Post Approval Study

    Sorry, in progress, not accepting new patients

    Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in "real-world" clinical practice. The Destination Therapy Post Approval Study (DT PAS) is conducted within Medtronic's Product Surveillance Platform.

    at UCSD UCSF

  • Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future

    Sorry, not yet accepting patients

    Durable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid to late 1990s, with an uptick of utility starting in 2010 following expanded indications for therapy to not only include a bridge to transplantation strategy, but also for those individuals who suffer from advanced heart failure (HF) and do not qualify for cardiac transplantation. Despite the decreasing size of the newest generation devices leading to a lessened occurrence of adverse events, bleeding and infection still remain a concern for clinicians, as well as a general lack of predictability towards adverse events in individuals with a dLVAD in place. There is a lack of description in the literature currently, regarding the interface between what the pump data provides and what is seen in clinical practice. There also is little known about the effects of what is provided in the pump data, in correlation to quality-of-life following dLVAD implantation. Therefore, the purpose of this study is to prospectively analyze normal and abnormal pump data through pump operations such as suction events, low flow alarms as well as other adventitious alarms, PI events and power cable disconnects greater than 20 seconds, from the HeartMate 3 ® dLVAD in order to clinically correlate this data to quality of life, frailty and other various medical conditions and adverse events as defined by the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs). This will be achieved through two aims: 1) Evaluate the effectiveness of dLVAD pump operations data on clinical practice application (quality of life, frailty and various medical conditions, and adverse events such as GIB, RHF, infection, hypertension, arrhythmias and stroke); and 2) Evaluate correlations and relationships of longitudinal normal and abnormal dLVAD pump operations data, to demographic and clinical variables. This study is the first study to evaluate HeartMate 3 ® dLVAD pump operations data over time for effectiveness in the clinical practice.

    at UCSF

Our lead scientists for Heart Failure research studies include .

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