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

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.

Study Overview

• Status: Completed
• Conditions: Post-Infarction Ventricular Septal Defect
• Intervention / Treatment: Device: AMPLATZER™ Post-infarct Muscular VSD 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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California at San Francisco
  • Florida
    • Gainesville, Florida, United States, 32610
      • Shands at the University of Florida
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University Hospital
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Butterworth Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center Fairview
  • New York
    • Buffalo, New York, United States, 14203
      • Buffalo General Hospital
    • New York, New York, United States, 10021
      • Lenox Hill Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina At Chapel Hill
    • Durham, North Carolina, United States, 27710
      • Duke University
    • High Point, North Carolina, United States, 27262
      • UNC Regional Physicians Carolina Cardiology
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan TriHealth Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital
    • Plano, Texas, United States, 75093
      • Baylor Scott & White
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • Spokane, Washington, United States, 99204
      • Providence Medical Research Group
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Month Visit
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
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Maren Wagner, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): November 29, 2021
• Study Completion (Actual): November 29, 2021

Study Registration Dates

• First Submitted: May 6, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Infarction; Heart Septal Defects, Ventricular
• Other Study ID Numbers: SJM-CIP-10191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes