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History of Changes for Study: NCT03165526
The AMPLATZERâ„¢ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) The AMPLATZERâ„¢ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study (PIVSD PAS)
Latest version (submitted December 7, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 22, 2017 None (earliest Version on record)
2 October 4, 2017 Study Status and Contacts/Locations
3 March 15, 2018 Recruitment Status, Contacts/Locations and Study Status
4 May 1, 2018 Study Status and Contacts/Locations
5 May 31, 2019 Contacts/Locations, Study Status and Study Identification
6 July 2, 2020 Study Status and Contacts/Locations
7 July 15, 2020 Contacts/Locations, Outcome Measures, Study Description and Study Status
8 April 19, 2021 Study Status, Eligibility, Groups and Interventions and Study Description
9 November 5, 2021 Contacts/Locations and Study Status
10 December 7, 2021 Recruitment Status, Study Status, Contacts/Locations, Study Design and Study Identification
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Study NCT03165526
Submitted Date:  May 22, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: SJM-CIP-10191
Brief Title: The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study (PIVSD PAS)
Official Title: The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2017
Overall Status: Not yet recruiting
Study Start: September 30, 2017
Primary Completion: September 30, 2020 [Anticipated]
Study Completion: September 30, 2020 [Anticipated]
First Submitted: May 6, 2017
First Submitted that
Met QC Criteria:
May 22, 2017
First Posted: May 24, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
May 22, 2017
Last Update Posted: May 24, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Abbott Medical Devices
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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 2 years. The total duration of the clinical study is expected to be 2.5 years.

Open or close this module Conditions
Conditions: Post-Infarction Ventricular Septal Defect
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Retrospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 30 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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 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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Effectiveness Endpoint 1: Technical Success
[ Time Frame: 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.
2. Effectiveness Endpoint 2: Acute Closure
[ Time Frame: Between 24 hours and 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 between 24 hours and 7 days post-procedure.
3. Effectiveness Endpoint 3: Chronic Closure
[ Time Frame: 6 Month Visit ]

Chronic closure is defined as the absence of a residual shunt ≥3 mm at 6 months.
4. Safety Endpoint 1: Acute Survival
[ Time Frame: Equal to or greater than 24 hours following an attempted PIVSD device implant ]

Acute survival is defined as survival for at least 24 hours following an attempted PIVSD device implant.
5. Safety Endpoint 2: Chronic Survival
[ Time Frame: Equal to or greater than 183 days from the time of first successful implant ]

Chronic survival is defined as survival for at least 183 days from the time of first successful implant.
Open or close this module Eligibility
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.

Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Ava Mayers
Telephone: 651-756-5576
Email: amayers@sjm.com
Central Contact Backup: Catherine Newcomb
Telephone: 651-756-2878
Email: cnewcomb@sjm.com
Study Officials: Ashish Oza, MS MBA
Study Director
Sponsor GmbH
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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