CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 131 enrolled
Drug / intervention
AMPLATZER™ Post-infarct Muscular VSD Occluderdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03165526
NCT03165526N/ACompleted
CompareCT.gov

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

Abbott Medical Devices·observational·Posted May 24, 2017·Updated Oct 10, 2024

In Brief

An observational study evaluating AMPLATZER™ Post-infarct Muscular VSD Occluder for Post-Infarction Ventricular Septal Defect. Completed, enrolled 131 participants across 17 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Infarction Ventricular Septal Defect
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 24, 2017
Enrollment StartOct 1, 2018
Primary CompletionNov 29, 2021
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.1 years ago

Interventions

AMPLATZER™ Post-infarct Muscular VSD Occluderdevice

The AMPLATZER™ PIVSD Occluder is intended for percutaneous transcatheter closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates.