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

Post-Infarction Ventricular Septal Defect Clinical Trial

— PIVSD PAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165526
• Other study ID #: SJM-CIP-10191
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: November 29, 2021

Study information

• Verified date: December 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 29, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Septal Defects, Ventricular
• Infarction
• Post-Infarction Ventricular Septal Defect

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University Hospital	Baltimore	Maryland
United States	Buffalo General Hospital	Buffalo	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Good Samaritan Trihealth Hospital	Cincinnati	Ohio
United States	Duke University	Durham	North Carolina
United States	Shands at the University of Florida	Gainesville	Florida
United States	Spectrum Health Butterworth Hospital	Grand Rapids	Michigan
United States	UNC Regional Physicians Carolina Cardiology	High Point	North Carolina
United States	Memorial Hermann Hospital	Houston	Texas
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	Lenox Hill Hospital	New York	New York
United States	Baylor Scott & White	Plano	Texas
United States	University of California at San Francisco	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	Providence Medical Research Group	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness Endpoint 1: Technical Success	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.	End of Implant Procedure
Primary	Effectiveness Endpoint 2: Acute Closure	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.	Up to 7 days post-procedure
Primary	Effectiveness Endpoint 3: Chronic Closure	Chronic closure is defined as the absence of a residual shunt =3 mm at 6 months or later.	6 Month Visit
Primary	Safety Endpoint 1: Acute Survival	Acute survival is defined as survival for at least 24 hours following an attempted PIVSD device implant.	Equal to or greater than 24 hours following an attempted PIVSD device implant
Primary	Safety Endpoint 2: Chronic Survival	Chronic survival is defined as survival for at least 183 days from the time of first successful implant.	Equal to or greater than 183 days from the time of first successful implant