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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
H070005 / PAS001 |
| Date Original Protocol Accepted |
04/13/2017
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| Date Current Protocol Accepted |
02/07/2021
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| Study Name |
AMPLATZER PIVSD Occluder PAS
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| Device Name |
THE AMPLATZER POST INFARCT MUSCULAR VSD OCCLUDER
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| General Study Protocol Parameters |
| Study Design |
Retrospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
To evaluate the safety and probable benefit of the AMPLATZER PIVSD Occluder in patients undergoing implantation of the PIVSD Occluder following an acute myocardial infarction. This is multicenter, retrospective non-randomized, observational study.
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| Study Population |
The intended population for the AMPLATZER™ PIVSD Occluder are patients with post-myocardial infarct muscular ventricular septal defect (VSD) who are not satisfactory surgical candidates. The study will enroll subjects in two cohorts:
First Cohort: All available Emergency and Compassionate PIVSD
Occluder subject data from 2011 to end of 2016.
All subjects belonging to this cohort must have undergone an attempt to close a post-infarct VSD using the AMPLATZER™ PIVSD Occluder.
Second Cohort: The second cohort will be comprised of subjects over the age of 18 who are successfully implanted with a PIVSD Occluder from 2011 onwards. The index procedure must have occurred >6 months prior to enrollment.
The subjects must meet following conditions:
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.
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| Sample Size |
First Cohort: All available Emergency and Compassionate PIVSD Occluder subject data from 2011 to the end of 2016.
Second Cohort: A total of 30 subjects who have been successfully implanted with PIVSD occluder and have data for the residual shunt assessed by the echocardiography core laboratory post procedure will be enrolled from up to 50 centers in the US.
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| Key Study Endpoints |
Cohort 1:
Acute Survival: is defined as survival for at least 24 hours following an attempted PIVSD device implant.
Chronic Survival: is defined as survival for at least 183 days post-procedure.
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.
Cohort 2:
Acute Closure: defined as the absence of a residual shunt greater than or equal to 3 mm, and will be assessed based on an echocardiogram obtained immediately after successful deployment of the device and up to 7 days post-procedure.
Chronic Closure: defined as the absence of a residual shunt greater than or equal to 3 mm at 6 months or later (where 6 months is defined as greater than or equal to 150 days)
Chronic Survival: is defined as survival for at least 183 days post-procedure.
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| Follow-up Visits and Length of Follow-up |
6 months
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Cohort 1- 99 patients
Cohort 2- 32 patients
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| Actual Number of Sites Enrolled |
Cohort 1- 64 investigational sites
Cohort 2- 16 investigational sites
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| Patient Follow-up Rate |
The data collected in this study is retrospective. Therefore the follow up rate is not relevant to tracking the progress of the study.
|
| Final Safety Findings |
Two safety endpoints were analyzed in this post-approval study: acute survival and chronic
survival. Acute and chronic survival were defined as survival for at least 24-hours post procedure
and for at least 183-days post-procedure, respectively. The primary safety endpoint results were as follows:
Acute Survival (Cohort 1): 84.3% (75/89)
Chronic Survival (Cohort 1 & 2): 37.2% and 46.4%, respectively
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| Final Effect Findings |
Three effectiveness endpoints were analyzed in this post-approval study: technical success, acute
closure, and chronic closure. Technical success was defined as successful implantation of the
PIVSD Occluder into the VSD. Acute and chronic closure were defined as the absence of a > 3 mm residual shunt immediately after deployment up to 7 days post-procedure and at 6-months post-procedure or later, respectively. The primary effectiveness endpoint results were as follows:
Technical Success (Cohort 1): 76.8% (76/99)
Acute Closure (Cohort 2): 53.1% (17/32)
Chronic Closure (Cohort 2): 66.7% (4/6)
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| Study Strengths & Weaknesses |
PIVSD is associated with high mortality (>90%) despite optimal medical treatment.
There is high mortality rate following surgical repair that ranges between 20% and 65%. Higher postoperative mortality correlates with early surgery (< 7 days) after the diagnosis. Of PIVSD.
Subjects included in this study were poor candidates for surgery (indication for treatment with the VSD device).
The results of the report demonstrate the Amplatzer™ PIVSD Occluder continues to be a safe alternative to medical therapy and surgical intervention for the repair of a VSD following a myocardial infarction in patients who are considered high risk surgical candidates.
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| Recommendations for Labeling Changes |
Yes, labeling recommended
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