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Device

AMPLATZER Device for Ventricular Septal Defects (VPA Trial)

N/A

Waitlist Available

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients meeting high-risk criteria for standard transatrial or transarterial surgical closure based on anatomical conditions

Patients with complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

VPA Trial Summary

This trial is designed to study the safety and effectiveness of the AMPLATZER Muscular VSD Occluder, which was approved by the FDA in 2007.

Who is the study for?

This trial is for patients with complex muscular ventricular septal defects (VSD) large enough to need closure, those with significant left to right heart shunt, pulmonary hypertension, or symptoms of heart failure. It's also for high-risk surgical candidates due to anatomical conditions and those who've had a banding procedure on the pulmonary artery.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of the AMPLATZER Muscular VSD Occluder device in patients after it has been implanted. This device was approved by FDA in September 2007 for closing muscular VSDs.See study design

What are the potential side effects?

While specific side effects are not listed here, similar procedures may include risks like irregular heart rhythms, bleeding or infection at the implant site, allergic reactions to device materials, or movement of the device after placement.

VPA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am considered high-risk for standard heart surgery due to my heart's structure.

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I have a significant hole in the heart muscle wall that needs closing.

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I have a significant heart shunt, high lung blood pressure, or symptoms of heart failure.

VPA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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.

VPA Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

Implantation with the device

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor

638 Previous Clinical Trials

404,097 Total Patients Enrolled

Maren WagnerStudy DirectorAbbott

3 Previous Clinical Trials

643 Total Patients Enrolled

Media Library

AMPLATZER Muscular VSD Occluder (Device) Clinical Trial Eligibility Overview. Trial Name: NCT00647387 — N/A

Ventricular Septal Defects Research Study Groups: 1

Ventricular Septal Defects Clinical Trial 2023: AMPLATZER Muscular VSD Occluder Highlights & Side Effects. Trial Name: NCT00647387 — N/A

AMPLATZER Muscular VSD Occluder (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00647387 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are conducting this research trial?

"This trial is enrolling participants at various medical institutions, such as the University of Iowa Hospitals & Clinics in Iowa City, Iowa; Medical University of South carolina in Charleston, South Carolina; and BC Children's Hospital in Vancouver, British Columbia. Additionally there are 51 other sites that have been approved for recruitment."

Answered by AI

Is recruitment currently ongoing for this clinical trial?

"The information on clinicaltrials.gov states that this particular research is no longer enrolling patients. The project was posted for the first time in March 2008 and last updated August 2022, with 11 other active trials available to prospective participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2008. "Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00647387.