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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AGA Medical Corporation
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00647387
First received: March 27, 2008
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Ventricular Septal Defects
Device: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:
  • The primary safety objective is to evaluate the proportion of subjects experiencing a major adverse event within 12 months of the procedure. Subjects will be followed for 5 years post implant. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Study Completion Date: September 2023
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Implantation with the device
Device: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
Device

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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
  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.
  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

Exclusion Criteria:

  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 woods 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647387

Contacts
Contact: Ava Mayers 651-756-5576

  Show 46 Study Locations
Sponsors and Collaborators
AGA Medical Corporation
  More Information

No publications provided

Responsible Party: AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00647387     History of Changes
Other Study ID Numbers: AGA-016
Study First Received: March 27, 2008
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:
muscular
ventricular
septal
defects
VSD

Additional relevant MeSH terms:
Heart Septal Defects, Ventricular
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 19, 2014