Trial Outcomes & Findings for The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study (NCT NCT03165526)
NCT ID: NCT03165526
Last Updated: 2024-10-10
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
131 participants
Primary outcome timeframe
End of Implant Procedure
Results posted on
2024-10-10
Participant Flow
Participant milestones
| Measure |
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.
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.
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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.
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.
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Overall Study
STARTED
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99
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32
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Overall Study
COMPLETED
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99
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32
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32).
Baseline characteristics by cohort
| Measure |
Amplatzer Post-Infarct Muscular VSCD Occluder Humanitarian Device Exemption Post-Approval Study
n=131 Participants
Cohort 1: 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.
Cohort 2: 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.
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.
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Age, Continuous
Cohort 1
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68.6 years
STANDARD_DEVIATION 11.9 • n=99 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32).
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Age, Continuous
Cohort 2
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66.4 years
STANDARD_DEVIATION 10.9 • n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32).
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Sex: Female, Male
Cohort 1 · Female
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46 Participants
n=99 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32)
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Sex: Female, Male
Cohort 1 · Male
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53 Participants
n=99 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32)
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Sex: Female, Male
Cohort 2 · Female
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15 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32)
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Sex: Female, Male
Cohort 2 · Male
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17 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32)
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Ethnicity (NIH/OMB)
Cohort 2 · Hispanic or Latino
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2 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Ethnicity was not collected for Cohort 1.
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Ethnicity (NIH/OMB)
Cohort 2 · Not Hispanic or Latino
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25 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Ethnicity was not collected for Cohort 1.
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Ethnicity (NIH/OMB)
Cohort 2 · Unknown or Not Reported
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5 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Ethnicity was not collected for Cohort 1.
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Race (NIH/OMB)
Cohort 2 · American Indian or Alaska Native
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0 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Race was not collected for Cohort 1.
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Race (NIH/OMB)
Cohort 2 · Asian
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0 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Race was not collected for Cohort 1.
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Race (NIH/OMB)
Cohort 2 · Native Hawaiian or Other Pacific Islander
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0 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Race was not collected for Cohort 1.
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Race (NIH/OMB)
Cohort 2 · Black or African American
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1 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Race was not collected for Cohort 1.
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Race (NIH/OMB)
Cohort 2 · White
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27 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Race was not collected for Cohort 1.
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Race (NIH/OMB)
Cohort 2 · More than one race
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0 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Race was not collected for Cohort 1.
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Race (NIH/OMB)
Cohort 2 · Unknown or Not Reported
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4 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Race was not collected for Cohort 1.
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Region of Enrollment
United States · Cohort 1
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99 Participants
n=131 Participants
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Region of Enrollment
United States · Cohort 2
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32 Participants
n=131 Participants
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Location of MI
Cohort 1 · Anterior (LAD)
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39 Participants
n=99 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32).
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Location of MI
Cohort 1 · Posterior/Inferior (RCA)
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47 Participants
n=99 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32).
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Location of MI
Cohort 1 · Lateral (Cicumflex)
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2 Participants
n=99 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32).
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Location of MI
Cohort 1 · Unknown
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11 Participants
n=99 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32).
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Location of MI
Cohort 2 · Anterior (LAD)
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14 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32).
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Location of MI
Cohort 2 · Posterior/Inferior (RCA)
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16 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32).
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Location of MI
Cohort 2 · Lateral (Cicumflex)
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1 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32).
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Location of MI
Cohort 2 · Unknown
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1 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32).
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Weight (kg)
Cohort 2
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81.48 kg
STANDARD_DEVIATION 16.76 • n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Weight was not collected for Cohort 1.
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Height (cm)
Cohort 2
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168.47 cm
STANDARD_DEVIATION 9.30 • n=31 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32).
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BMI
Cohort 2
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28.34 kg/m^2
STANDARD_DEVIATION 5.62 • n=31 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). BMI was not collected for Cohort 1. Data was available for 31/32 of Cohort 2 subjects.
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Medical History
Cohort 2 - Hypertension
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21 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Medical History was not collected for Cohort 1. Data was available for 29 and 31 of the Cohort 2 subjects for hyperlipidemia and history of smoking, respectively.
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Medical History
Cohort 2 - Diabetes
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10 Participants
n=32 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Medical History was not collected for Cohort 1. Data was available for 29 and 31 of the Cohort 2 subjects for hyperlipidemia and history of smoking, respectively.
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Medical History
Cohort 2 - Hyperlipidemia
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19 Participants
n=29 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Medical History was not collected for Cohort 1. Data was available for 29 and 31 of the Cohort 2 subjects for hyperlipidemia and history of smoking, respectively.
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Medical History
Cohort 2 - History of Smoking
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18 Participants
n=31 Participants • The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). Medical History was not collected for Cohort 1. Data was available for 29 and 31 of the Cohort 2 subjects for hyperlipidemia and history of smoking, respectively.
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PRIMARY outcome
Timeframe: End of Implant ProcedurePopulation: The analysis population includes all Emergency and Compassionate PIVSD subjects who have an attempted device placement (defined as the delivery system enters the subject's vasculature in an attempt to place a device) from 2011 until the end of 2016.
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.
Outcome measures
| Measure |
Cohort 1
n=99 Participants
Cohort 1 consisted of all Emergency and Compassionate PIVSD subjects who have an attempted device placement (defined as the delivery system enters the subject's vasculature in an attempt to place a device) from 2011 until the end of 2016 (n=99).
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Cohort 2
Cohort 2 consists of subjects who have been previously implanted with the PIVSD Occluder
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Effectiveness Endpoint 1: Technical Success
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76 Participants
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—
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PRIMARY outcome
Timeframe: Up to 7 days post-procedurePopulation: The analysis population will include all enrolled subjects, i.e., this population will include subjects from Cohort 2 which will be comprised of subjects who have previously been successfully implanted with the PIVSD Occluder, the subject's post-procedure echocardiogram is able to be evaluated for residual shunt by the echocardiography core laboratory, and, for living subjects, informed consent has been obtained.
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.
Outcome measures
| Measure |
Cohort 1
n=32 Participants
Cohort 1 consisted of all Emergency and Compassionate PIVSD subjects who have an attempted device placement (defined as the delivery system enters the subject's vasculature in an attempt to place a device) from 2011 until the end of 2016 (n=99).
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Cohort 2
Cohort 2 consists of subjects who have been previously implanted with the PIVSD Occluder
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Effectiveness Endpoint 2: Acute Closure
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17 Participants
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—
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PRIMARY outcome
Timeframe: 6 months or later following a PIVSD device implant through study completion, an average of 1 yearPopulation: The analysis population will include enrolled subjects from Cohort 2 with an implanted PIVSD device who have a 6-months or later post-procedure echocardiogram available for review.
Chronic closure is defined as the absence of a residual shunt ≥3 mm at 6 months or later.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Cohort 1 consisted of all Emergency and Compassionate PIVSD subjects who have an attempted device placement (defined as the delivery system enters the subject's vasculature in an attempt to place a device) from 2011 until the end of 2016 (n=99).
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Cohort 2
Cohort 2 consists of subjects who have been previously implanted with the PIVSD Occluder
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Effectiveness Endpoint 3: Chronic Closure
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4 Participants
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—
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PRIMARY outcome
Timeframe: Equal to or greater than 24 hours following an attempted PIVSD device implant through study completion, up to 9.7 years post-procedurePopulation: The analysis population will include all Emergency and Compassionate PIVSD subjects who have an attempted device placement from 2011 until the end of 2016 but will exclude subjects whose survival status is not known through at least 24 hours after the procedure.
Acute survival is defined as survival for at least 24 hours following an attempted PIVSD device implant.
Outcome measures
| Measure |
Cohort 1
n=89 Participants
Cohort 1 consisted of all Emergency and Compassionate PIVSD subjects who have an attempted device placement (defined as the delivery system enters the subject's vasculature in an attempt to place a device) from 2011 until the end of 2016 (n=99).
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Cohort 2
Cohort 2 consists of subjects who have been previously implanted with the PIVSD Occluder
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Safety Endpoint 1: Acute Survival
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75 Participants
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—
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PRIMARY outcome
Timeframe: Equal to or greater than 183 days from the time of first successful implant through study completion, up to 9.7 years post-procedurePopulation: The analysis will be conducted on both cohorts. The first analysis population is Cohort 1(all Emergency and Compassionate PIVSD subjects who have an attempted device placement from 2011 until the end of 2016). The second analysis population is Cohort 2 (those previously implanted with the PIVSD Occluder, provided informed consent (for living subjects only), and the subject's post-procedure echocardiogram is able to be evaluated for residual shunt by the echocardiography core laboratory).
Chronic survival is defined as survival for at least 183 days from the time of first successful implant.
Outcome measures
| Measure |
Cohort 1
n=99 Participants
Cohort 1 consisted of all Emergency and Compassionate PIVSD subjects who have an attempted device placement (defined as the delivery system enters the subject's vasculature in an attempt to place a device) from 2011 until the end of 2016 (n=99).
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Cohort 2
n=32 Participants
Cohort 2 consists of subjects who have been previously implanted with the PIVSD Occluder
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Safety Endpoint 2: Chronic Survival
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37.2 percentage of participants
Interval 27.0 to 47.3
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46.4 percentage of participants
Interval 27.9 to 63.1
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Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 59 deaths
Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 16 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER