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

CompletedOBSERVATIONAL
Enrollment

131

Participants

Timeline

Start Date

October 1, 2018

Primary Completion Date

November 29, 2021

Study Completion Date

November 29, 2021

Conditions
Post-Infarction Ventricular Septal Defect
Interventions
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.

Trial Locations (17)

10021

Lenox Hill Hospital, New York

14203

Buffalo General Hospital, Buffalo

21287

Johns Hopkins University Hospital, Baltimore

27262

UNC Regional Physicians Carolina Cardiology, High Point

27599

University of North Carolina at Chapel Hill, Chapel Hill

27710

Duke University, Durham

32610

Shands at the University of Florida, Gainesville

45220

Good Samaritan Trihealth Hospital, Cincinnati

49503

Spectrum Health Butterworth Hospital, Grand Rapids

53792

University of Wisconsin Hospital and Clinics, Madison

54449

Marshfield Clinic, Marshfield

55455

University of Minnesota Medical Center Fairview, Minneapolis

75093

Baylor Scott & White, Plano

77030

Memorial Hermann Hospital, Houston

94143

University of California at San Francisco, San Francisco

98122

Swedish Medical Center, Seattle

99204

Providence Medical Research Group, Spokane

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY

NCT03165526 - The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study | Biotech Hunter | Biotech Hunter