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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 belowSelect...
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
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
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
640 Previous Clinical Trials
405,729 Total Patients Enrolled
Maren WagnerStudy DirectorAbbott
3 Previous Clinical Trials
643 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a hole in my heart after a heart attack.I am considered high-risk for standard heart surgery due to my heart's structure.My overall health is stable.My heart defect is close to the heart valves.I weigh less than 5.2 kg.I currently have an active bacterial infection.I cannot take anti-platelet medications due to health reasons.I have a significant hole in the heart muscle wall that needs closing.My doctor thinks closing the hole in my heart is necessary.I have severe lung blood pressure issues and irreversible lung vessel disease.I have a hole in my heart near the aortic valve.I have an infection that has spread throughout my body.I have a significant heart shunt, high lung blood pressure, or symptoms of heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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