CompletedNot Applicable

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

United States92 participantsStarted 2008-03

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. Subjects must meet at least one of the following:
✓. Large volume left to right shunt (Qp/Qs \>2:1),
✓. Pulmonary hypertension (PA pressure \>50% systemic) and/or
✓. Clinical symptoms of congestive heart failure
✓. Banding of the pulmonary artery(ies) and in the opinion of the treating investigator closure of the VSD is clinically warranted.
✓. 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:
✓. Left ventriculotomy or an extensive right ventriculotomy,
✓. Failed previous VSD closure,

Exclusion criteria

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

What they're measuring

Primary Effectiveness End Point: Technical Success

Timeframe: During the procedure

Primary Effectiveness End Point: Acute Procedure Success

Timeframe: At the end of the procedure

Primary Effectiveness End Point: Shunt Closure Success

Timeframe: 1-year follow-up visit

Primary Safety Endpoint

Timeframe: Within 12 months of the procedure

Trial details

NCT IDNCT00647387

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-23

Results submitted2025-01-16

View on ClinicalTrials.gov More Ventricular Septal Defects trials