Ventricular Septal DefectsVPANCT00647387

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

A study testing Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder) in people with Ventricular Septal Defects, run by Abbott Medical Devices at 51 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Ventricular Septal Defects
What is being tested?: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 51 sitesin 2 countries
Study dates: Mar 2008to 23 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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:

Show all 13Show fewer

Left ventriculotomy or an extensive right ventriculotomy,
Failed previous VSD closure,
Multiple apical and/or anterior muscular VSDs ("Swiss Cheese Septum"), and/or
Posterior apical VSDs covered by trabeculae.
Overall medical condition
Subject/legally authorized representative has signed the informed consent
Subject/legally authorized representative is willing to complete the follow-up requirements of this study

Who cannot join

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

Trial locations and contacts

51 sites in 2 countries.

Country

City, postcode or hospital

51 sites in 2 countries

United States48 sites

Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Augusta University
Augusta, Georgia, 30912
Children's Hospital of Colorado
Aurora, Colorado, 80045
University of Maryland Medical Center
Baltimore, Maryland, 21201
Deborah Heart & Lung Center
Browns Mills, New Jersey, 08015
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia Medical Center
Charlottesville, Virginia, 22908
University of Chicago Medical Center
Chicago, Illinois, 60637
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Children's Hospital of Michigan
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Texas Children's Hospital
Houston, Texas, 77030
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Missouri-Kansas City School of Medicine
Kansas City, Missouri, 64108
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Sunrise Hospital
Las Vegas, Nevada, 89109
University of Kentucky
Lexington, Kentucky, 40536
Children's Hospital Los Angeles (USC)
Los Angeles, California, 90027
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Valley Children's Hospital
Madera, California, 93638
Methodist LeBonheur Healthcare
Memphis, Tennessee, 38104
Jackson Memorial Hospital
Miami, Florida, 33136
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
Yale New Haven Hospital
New Haven, Connecticut, 06510-3202
Children's Hospital of New York-Presbyterian
New York, New York, 10032
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Arnold Palmer Hospital
Orlando, Florida, 32806
Stanford University Medical Center
Palo Alto, California, 94304
St. Joseph Hospital and Medical Center
Phoenix, Arizona, 85013
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Mayo Clinic
Rochester, Minnesota, 55905
Rady Children's Hospital
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
St. Louis Children's Hospital
St Louis, Missouri, 63110
All Children's Hospital
St. Petersburg, Florida, 33701
Munson Medical Center
Traverse City, Michigan, 49684
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803

Other trials in United States

Canada3 sites

Hopital Sainte-Justine
Montreal, Quebec
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
BC Children's Hospital
Vancouver, Bristish Columbia, V6H3N1

Other trials in Canada

About this study

Conditions: Ventricular Septal Defects
Being tested: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
Keywords: muscular, ventricular, septal, defects, VSD
Medical subject headings: Heart Septal Defects, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00647387
Study group	Role	What they receive
Muscular VSD Occluder	Experimental	Implantation with the device Receives: Device: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Effectiveness End Point: Technical Success
Technical success was defined as successful deployment of the device (Amplatzer™ Muscular VSD Occluder) in subjects with the ventricular septal defect (VSD).
Measured: During the procedure
Primary Effectiveness End Point: Acute Procedure Success
Acute procedural success was defined as a defect with a ≤ 2mm residual shunt at the conclusion of the procedure, as reported by clinical sites.
Measured: At the end of the procedure
Primary Effectiveness End Point: Shunt Closure Success
Subjects in whom a defect has ≤ 2 mm residual shunt at the 1-year follow-up visit (as evaluated by the independent echocardiography board).
Measured: 1-year follow-up visit
Primary Safety Endpoint
The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure.
Measured: Within 12 months of the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 200823 Feb 2024

First posted31 Mar 2008 (estimated)
Study startMar 2008
Primary completion23 Feb 2024
Study completion23 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ventricular Septal DefectsStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00647387
Sponsor's protocol ID: AGA-016
Acronym: VPA
Status last verified: Feb 2025
First submitted: 27 Mar 2008
Last updated: 11 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Qureshi AM, Justino H, Owada C, Numan M, Ebeid M, Forbes TJ, Nykanen D, Kobayashi D, Kolles J, Gutfinger D, Balzer D. Postapproval Study Outcomes of Muscular Ventricular Septal Defect Closure With the Amplatzer Muscular VSD Occluder. Circ Cardiovasc Interv. 2026 Jun;19(6):e016121. doi: 10.1161/CIRCINTERVENTIONS.125.016121. Epub 2026 May 5.
PubMed 42083863

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
RecruitingObservational study
An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects
Perimembranous Ventricular Septal Defect
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Abbott Structural Heart Device Registry
Heart Diseases, ASD - Atrial Septal Defect
RecruitingObservational study
A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children
Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD)
RecruitingObservational study
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
Muscular Ventricular Septal Defect

All Ventricular Septal Defects trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
ClinicalTrials.gov ID: NCT00647387
Acronym / sponsor ID: VPA / AGA-016
Conditions: Ventricular Septal Defects
Keywords: muscular, ventricular, septal, defects, VSD
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Mar 2008 (actual)
Primary completion: 23 Feb 2024 (actual)
Study completion: 23 Feb 2024 (actual)
First posted: 31 Mar 2008 (estimated)
Results: Posted 7 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Muscular VSD Occluder	Experimental	Device: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)Implantation with the device

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (13 listed)

complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. Subjects must meet at least one of the following:
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:
Subject/legally authorized representative has signed the informed consent
Subject/legally authorized representative is willing to complete the follow-up requirements of this study

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)Device	Device	Muscular VSD Occluder

Primary outcome

Primary Effectiveness End Point: Technical Success
Time frame: During the procedure
Technical success was defined as successful deployment of the device (Amplatzer™ Muscular VSD Occluder) in subjects with the ventricular septal defect (VSD).
Primary Effectiveness End Point: Acute Procedure Success
Time frame: At the end of the procedure
Acute procedural success was defined as a defect with a ≤ 2mm residual shunt at the conclusion of the procedure, as reported by clinical sites.
Primary Effectiveness End Point: Shunt Closure Success
Time frame: 1-year follow-up visit
Subjects in whom a defect has ≤ 2 mm residual shunt at the 1-year follow-up visit (as evaluated by the independent echocardiography board).
Primary Safety Endpoint
Time frame: Within 12 months of the procedure
The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure.

Results and safety

Results posted to the registry on 7 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Muscular VSD Occluder	92	73

Primary outcome: Primary Effectiveness End Point: Technical Success

Time frame: During the procedure. Count of participants. Unit: Participants

Measure	Muscular VSD Occluder n = 80
Value	75

Population analysed: The analysis population included all prospectively enrolled subjects only (N=80) who have an attempted device placement (defined as the delivery system enters the subject's body in an attempt to place a device), as retrospectively enrolled subjects were selected based on established Technical Success.

Primary outcome: Primary Effectiveness End Point: Acute Procedure Success

Time frame: At the end of the procedure. Count of participants. Unit: Participants

Measure	Muscular VSD Occluder n = 91
Value	71

Population analysed: The analysis population included all subjects who had an attempted device placement (defined as the delivery system enters the subject's body in an attempt to place a device).

Primary outcome: Primary Effectiveness End Point: Shunt Closure Success

Time frame: 1-year follow-up visit. Count of participants. Unit: Participants

Measure	Muscular VSD Occluder n = 72
Value	68

Population analysed: The analysis of the shunt closure success included all enrolled subjects who had an attempted device placement (defined as the delivery system enters the subject's body in an attempt to place a device) and a 1-year follow-up visit.

Primary outcome: Primary Safety Endpoint

Time frame: Within 12 months of the procedure. Count of participants. Unit: Participants

Measure	Muscular VSD Occluder n = 90
Value	47

Population analysed: The Primary Safety endpoint included all enrolled subjects except for withdrawn subjects with no adverse events within the first 12 months and consented screen failures.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Muscular VSD Occluder	51 of 92 (55.4%)	17 of 92 (18.5%)	2 of 92

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42083863Qureshi AM, Justino H, Owada C, Numan M, Ebeid M, Forbes TJ, Nykanen D, Kobayashi D, Kolles J, Gutfinger D, Balzer D. Postapproval Study Outcomes of Muscular Ventricular Septal Defect Closure With the Amplatzer Muscular VSD Occluder. Circ Cardiovasc Interv. 2026 Jun;19(6):e016121. doi: 10.1161/CIRCINTERVENTIONS.125.016121. Epub 2026 May 5.

Related trials for Ventricular Septal Defects

Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
RecruitingObservational study
An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects
Perimembranous Ventricular Septal Defect
RecruitingObservational study
Abbott Structural Heart Device Registry
Heart Diseases, ASD - Atrial Septal Defect
RecruitingObservational study
A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children
Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD)
RecruitingObservational study
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
Muscular Ventricular Septal Defect

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

51 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder) in people with Ventricular Septal Defects, run by Abbott Medical Devices at 51 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness End Point: Technical Success (time frame: During the procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00647387, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.