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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 December 2016 by St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: March 27, 2008
Last updated: December 14, 2016
Last verified: December 2016
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 St. Jude Medical:

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 ]

Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Study Completion Date: September 2023
Estimated Primary Completion Date: December 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)


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT00647387

Contact: Ava Mayers 651-756-5576

  Show 46 Study Locations
Sponsors and Collaborators
St. Jude Medical
Study Director: Ashish Oza St. Jude Medical
  More Information

Responsible Party: St. Jude Medical Identifier: NCT00647387     History of Changes
Other Study ID Numbers: AGA-016
Study First Received: March 27, 2008
Last Updated: December 14, 2016

Keywords provided by St. Jude Medical:

Additional relevant MeSH terms:
Heart Septal Defects, Ventricular
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities processed this record on April 24, 2017