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

NCT03165526 | Completed Results FDA Device

• 1 other identifier: SJM-CIP-10191
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 17

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.

Conditions

Post-Infarction Ventricular Septal Defect

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• Effectiveness Endpoint 3: Chronic Closure

  Chronic closure is defined as the absence of a residual shunt ≥3 mm at 6 months or later.

  6 months or later following a PIVSD device implant through study completion, an average of 1 year

• 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 through study completion, up to 9.7 years post-procedure

• 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 through study completion, up to 9.7 years post-procedure

Study Arms (2)

First Cohort

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.

Device: AMPLATZER™ Post-infarct Muscular VSD Occluder

Second Cohort

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.

Device: AMPLATZER™ Post-infarct Muscular VSD Occluder

Interventions

AMPLATZER™ Post-infarct Muscular VSD Occluder DEVICE

The AMPLATZER™ PIVSD Occluder is intended for percutaneous transcatheter closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates.

First Cohort; Second Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (17)

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Shands at the University of Florida

Gainesville, Florida, 32610, United States

Location

Johns Hopkins University Hospital

Baltimore, Maryland, 21287, United States

Location

Spectrum Health Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

Location

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455, United States

Location

Buffalo General Hospital

Buffalo, New York, 14203, United States

Location

Lenox Hill Hospital

New York, New York, 10021, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

UNC Regional Physicians Carolina Cardiology

High Point, North Carolina, 27262, United States

Location

Good Samaritan Trihealth Hospital

Cincinnati, Ohio, 45220, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Baylor Scott & White

Plano, Texas, 75093, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Providence Medical Research Group

Spokane, Washington, 99204, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Results Point of Contact

• Title: Courtney Weiler
• Organization: Abbott Medical Device

ClinicalTrials.gov_SH_Inquiries@abbott.com

224 430 4918

Study Officials

• Ryan Palmer

  Sponsor GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2017
• First Posted: May 24, 2017
• Study Start: October 1, 2018
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)