Clinical trial NCT03165526: The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
Official title: The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Infarction Ventricular Septal Defect
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-05-24
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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: This cohort will consist of subjects over the age of 18 years who have previously been successfully implanted with the AMPLATZER™ PIVSD Occluder.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness Endpoint 1: Technical Success
timeFrame: End of Implant Procedure
measure: Effectiveness Endpoint 2: Acute Closure
timeFrame: Up to 7 days post-procedure
measure: Effectiveness Endpoint 3: Chronic Closure
timeFrame: 6 months or later following a PIVSD device implant through study completion, an average of 1 year
measure: 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
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Gainesville
country: United States
facility: Shands at the University of Florida
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University Hospital
state: Maryland
city: Grand Rapids
country: United States
facility: Spectrum Health Butterworth Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: Buffalo
country: United States
facility: Buffalo General Hospital
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: High Point
country: United States
facility: UNC Regional Physicians Carolina Cardiology
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Trihealth Hospital
state: Ohio
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: Providence Medical Research Group
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
Study officials:
affiliation: Sponsor GmbH
name: Ryan Palmer
role: STUDY_DIRECTOR
References: