This study is in progress, not accepting new patients

Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study

a study on Ventricular Septal Defects

Summary

Location
at UCLA
Dates
study started
completion around

Description

Summary

The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.

Keywords

Ventricular Septal Defects, muscular, ventricular, septal, defects, VSD, Heart Septal Defects, Ventricular Heart Septal Defects, Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)

Eligibility

You can join if…

  1. complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. Subjects must meet at least one of the following:
    1. Large volume left to right shunt (Qp/Qs >2:1),
    2. Pulmonary hypertension (PA pressure >50% systemic) and/or
    3. Clinical symptoms of congestive heart failure
    4. Banding of the pulmonary artery(ies) and in the opinion of the treating investigator closure of the VSD is clinically warranted.
  2. Subjects must meet at least one of the following criteria to be considered high risk for standard transatrial or transarterial surgical closure based on anatomical conditions:
    1. Left ventriculotomy or an extensive right ventriculotomy,
    2. Failed previous VSD closure,
    3. Multiple apical and/or anterior muscular VSDs ("Swiss Cheese Septum"), and/or
    4. Posterior apical VSDs covered by trabeculae.
    5. Overall medical condition
  3. Subject/legally authorized representative has signed the informed consent
  4. Subject/legally authorized representative is willing to complete the follow-up requirements of this study

You CAN'T join if...

  1. Subjects with defects less than 4 mm distance from the semilunar (aortic and pulmonary) or atrioventricular valves (mitral and tricuspid)
  2. Subjects with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease
  3. Subjects with perimembranous (close to the aortic valve) VSD
  4. Subjects with post-infarction VSD
  5. Subjects who weigh < 5.2 kg
  6. Subjects with sepsis (local/generalized)
  7. Subjects with active bacterial infections
  8. Subjects with contraindications to anti-platelets

Locations

  • Ronald Reagan UCLA Medical Center
    Los Angeles California 90095 United States
  • Cedars-Sinai Medical Center
    Los Angeles California 90048 United States
  • Rady Children's Hospital
    San Diego California 92123 United States
  • Children's Hospital Los Angeles (USC)
    Los Angeles California 90027 United States
  • Valley Children's Hospital
    Madera California 93638 United States
  • Stanford University Medical Center
    Palo Alto California 94304 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT00647387
Study Type
Interventional
Participants
About 91 people participating
Last Updated