The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
- Conditions
- Post-Infarction Ventricular Septal Defect
- Interventions
- Device: AMPLATZER™ Post-infarct Muscular VSD Occluder
- Registration Number
- NCT03165526
- Lead Sponsor
- Abbott Medical Devices
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description First Cohort AMPLATZER™ Post-infarct Muscular VSD Occluder All available Emergency and Compassionate PIVSD Occluder subject data from 2011 until the end of 2016 will be utilized to determine technical success and acute survival. All subjects belonging to this cohort must have undergone an attempt to close a post-infarct VSD using the AMPLATZER™ PIVSD Occluder. Second Cohort AMPLATZER™ Post-infarct Muscular VSD Occluder This cohort will consist of subjects over the age of 18 years who have previously been successfully implanted with the PIVSD Occluder and * 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. Therefore, this cohort will be composed of retrospectively enrolled subjects. This cohort will be utilized to determine acute and chronic closure and chronic survival.
- Primary Outcome Measures
Name Time Method Safety Endpoint 1: Acute Survival Equal to or greater than 24 hours following an attempted PIVSD device implant through study completion, up to 9.7 years post-procedure Acute survival is defined as survival for at least 24 hours following an attempted PIVSD device implant.
Safety Endpoint 2: Chronic Survival Equal to or greater than 183 days from the time of first successful implant through study completion, up to 9.7 years post-procedure Chronic survival is defined as survival for at least 183 days from the time of first successful implant.
Effectiveness Endpoint 3: Chronic Closure 6 months or later following a PIVSD device implant through study completion, an average of 1 year Chronic closure is defined as the absence of a residual shunt ≥3 mm at 6 months or later.
Effectiveness Endpoint 1: Technical Success End of Implant Procedure Technical success occurs when a subject is successfully implanted with a PIVSD device in the ventricular septal defect. An implant attempt occurs when the delivery system is inserted in the subject's vasculature.
Effectiveness Endpoint 2: Acute Closure Up to 7 days post-procedure Acute closure is defined as the absence of a residual shunt ≥3 mm, and will be assessed based on an echocardiogram obtained immediately after the successful deployment of the device and up to 7 days post-procedure.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
University of California at San Francisco
🇺🇸San Francisco, California, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Baylor Scott & White
🇺🇸Plano, Texas, United States
UNC Regional Physicians Carolina Cardiology
🇺🇸High Point, North Carolina, United States
Providence Medical Research Group
🇺🇸Spokane, Washington, United States
Duke University
🇺🇸Durham, North Carolina, United States
Good Samaritan Trihealth Hospital
🇺🇸Cincinnati, Ohio, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Shands at the University of Florida
🇺🇸Gainesville, Florida, United States
Spectrum Health Butterworth Hospital
🇺🇸Grand Rapids, Michigan, United States
Johns Hopkins University Hospital
🇺🇸Baltimore, Maryland, United States
Buffalo General Hospital
🇺🇸Buffalo, New York, United States
University of Minnesota Medical Center Fairview
🇺🇸Minneapolis, Minnesota, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States