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

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Ventricular septal defects
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Brief Title

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

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.

Study Type

Interventional

Primary Outcome

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.

Condition

Ventricular Septal Defects

Intervention

Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)

Study Arms / Comparison Groups

 1
Description:  Implantation with the device

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

91

Start Date

March 2008

Completion Date

May 2025

Primary Completion Date

March 2021

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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Maren Wagner, ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT00647387

Organization ID

AGA-016

Responsible Party

Sponsor

Study Sponsor

Abbott Medical Devices

Study Sponsor

Maren Wagner, Study Director, Abbott

Verification Date

April 2021