NCT03165526

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 131 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-center, observational study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD Occluder for use in transcatheter closure of muscular ventricular septal defects following a myocardial infarction in the post approval setting. The study has five endpoints (safety: acute and chronic survival; effectiveness: technical success, acute and chronic closure).Two cohorts will be utilized to obtain study endpoint data. The first cohort will be comprised of all available Emergency and Compassionate PIVSD Occluder subject data from 2011 until the end of 2016 and these data will be used to determine technical success and acute survival. The second cohort of thirty subjects will be comprised of patients who are successfully implanted with a PIVSD Occluder from 2011 onward at activated study centers. The index procedure must have occurred \>6 months prior to enrollment. Subject identification will occur until data on a minimum of 30 subjects with PIVSD Occluders for post myocardial infarct VSD and post-procedure echocardiogram available for evaluation of residual shunt by the echocardiography core laboratory have been enrolled. The thirty subject cohort data will be used to determine acute closure, chronic closure, and chronic survival endpoints. The study will be conducted at up to 50 centers in the U.S. The expected duration of enrollment is approximately 4 years. The total duration of the clinical study is expected to be 4.5 years.

Conditions

• Post-Infarction Ventricular Septal Defect

Interventions

Type	Name	Description
DEVICE	AMPLATZER™ Post-infarct Muscular VSD Occluder	The AMPLATZER™ PIVSD Occluder is intended for percutaneous transcatheter closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates.

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-11-29
• Completion: 2021-11-29
• First posted: 2017-05-24
• Last updated: 2024-10-10
• Results posted: 2024-10-10

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study