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University of Texas Health Science Center at Houston | McGovern Medical School - ACTAT - Research Department

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

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Abbott

Status

Completed

Conditions

Ventricular Septal Defects

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00647387
AGA-016

Details and patient eligibility

About

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.

Enrollment

91 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

91 participants in 1 patient group

1
Experimental group
Description:
Implantation with the device
Treatment:
Device: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)

Trial contacts and locations

51

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Data sourced from clinicaltrials.gov

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