CompletedNot Applicable

The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study

United States131 participantsStarted 2018-10-01

Plain-language summary

FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD Occluder (H070005) on January 10, 2017. The Conditions of Approval require that SJM conduct a post approval study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD Occluder.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

First Cohort: Patients who have undergone an attempt to close a post-infarct VSD using the AMPLATZER™ PIVSD Occluder via Emergency and Compassionate 2011 until the end of 2016. Second Cohort: * Over 18 years old * Patients who have previously been successfully implanted with the AMPLATZER™ PIVSD Occluder * For living subjects, the subject or subject's legally authorized representative has provided consent to participate in this study * Subject's post-procedure echocardiogram is evaluable and can be sent to the echocardiography core laboratory for residual shunt assessment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effectiveness Endpoint 1: Technical Success

Timeframe: End of Implant Procedure

Effectiveness Endpoint 2: Acute Closure

Timeframe: Up to 7 days post-procedure

Effectiveness Endpoint 3: Chronic Closure

Timeframe: 6 months or later following a PIVSD device implant through study completion, an average of 1 year

Safety Endpoint 1: Acute Survival

Timeframe: Equal to or greater than 24 hours following an attempted PIVSD device implant through study completion, up to 9.7 years post-procedure

Safety Endpoint 2: Chronic Survival

Timeframe: Equal to or greater than 183 days from the time of first successful implant through study completion, up to 9.7 years post-procedure

Trial details

NCT IDNCT03165526

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-11-29

Results submitted2022-10-14

View on ClinicalTrials.gov More Post-Infarction Ventricular Septal Defect trials