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

• ClinicalTrials.gov Identifier: NCT00647387
• Recruitment Status: Active, not recruiting
• First Posted: March 31, 2008
• Last Update Posted: August 5, 2022
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Tracking Information

• First Submitted Date: March 27, 2008
• First Posted Date: March 31, 2008
• Last Update Posted Date: August 5, 2022
• Actual Study Start Date: March 2008
• Estimated Primary Completion Date: August 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 7, 2008): 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 ]
• Original Primary Outcome Measures (submitted: March 28, 2008): The primary safety objective is to evaluate the proportion of subjects experiencing a major adverse event within 12 months of the procedure. [ Time Frame: 12 months ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
• Official Title: Not Provided
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ventricular Septal Defects

Intervention

Device: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)

Device

Study Arms

Experimental: 1

Implantation with the device

Intervention: Device: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 2, 2020): 91
• Original Estimated Enrollment (submitted: March 28, 2008): 100
• Estimated Study Completion Date: August 2025
• Estimated Primary Completion Date: August 2025 (Final data collection date for primary outcome measure)

Eligibility 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
   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

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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT00647387
• Other Study ID Numbers: AGA-016
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Abbott Medical Devices
• Original Responsible Party: Ken Lock, Director of Clinical Affairs, AGA Medical Corporation
• Current Study Sponsor: Abbott Medical Devices
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Maren Wagner; Abbott

• PRS Account: Abbott Medical Devices
• Verification Date: August 2022