Product Surveillance Registry

a study on Cardiac Rhythm Disorders Urological Disorders Neurological Disorders Cardiovascular Disorders Digestive Disorders Aneurysm Mechanical Circulatory Support Respiratory Therapy Aortic, Peripheral Vascular and Venous Disorders Minimally Invasive Surgical Procedures Diagnostic Techniques and Procedures Surgical Procedures, Operative Renal Insufficiency Neurovascular Coronary Artery Disease Peripheral Artery Disease Ear, Nose and Throat Disorder Cardiovascular Disease Cardiac Arrhythmia

Summary

Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Jessica Stewart (ucla)

Description

Summary

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Official Title

Medtronic Product Surveillance Registry

Keywords

Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders, Digestive Disorders, Intracranial Aneurysm, Mechanical Circulatory Support, Respiratory Therapy, Aortic, Peripheral Vascular and Venous Disorders, Minimally Invasive Surgical Procedures, Diagnostic Techniques and Procedures, Surgical Procedures, Operative, Renal Insufficiency, Neurovascular, Coronary Artery Disease, Ear, Nose and Throat Disorder, Digestive System Diseases, Nervous System Diseases, Urologic Diseases, Aneurysm, Cardiovascular Diseases, Cardiac Arrhythmias

Eligibility

You can join if…

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient has or is intended to receive or be treated with an eligible Medtronic product
  • Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment

You CAN'T join if...

  • Patient who is, or will be, inaccessible for follow-up
  • Patient with exclusion criteria required by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Locations

  • Aliso Viejo California United States
  • Van Nuys California United States
  • Los Angeles California United States
  • San Diego California United States
  • Torrance California United States
  • Chula Vista California United States
  • Redwood City California United States
  • Carlsbad California United States
  • Stanford California United States

Lead Scientist at University of California Health

  • Jessica Stewart (ucla)
    HS Assistant Clinical Professor, Radiological Sciences, Medicine. Authored (or co-authored) 4 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic
ID
NCT01524276
Study Type
Observational
Participants
Expecting 100000 study participants
Last Updated