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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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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
Therefore, this cohort will be composed of retrospectively enrolled subjects. This cohort will be utilized to determine acute and chronic closure and chronic survival. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 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 |
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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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Palmer | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Francisco | San Francisco | California | 94143 | United States | ||
| Shands at the University of Florida |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2020 |
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| Gainesville |
| Florida |
| 32610 |
| United States |
| Johns Hopkins University Hospital | Baltimore | Maryland | 21287 | United States |
| Spectrum Health Butterworth Hospital | Grand Rapids | Michigan | 49503 | United States |
| University of Minnesota Medical Center Fairview | Minneapolis | Minnesota | 55455 | United States |
| Buffalo General Hospital | Buffalo | New York | 14203 | United States |
| Lenox Hill Hospital | New York | New York | 10021 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| UNC Regional Physicians Carolina Cardiology | High Point | North Carolina | 27262 | United States |
| Good Samaritan Trihealth Hospital | Cincinnati | Ohio | 45220 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| Baylor Scott & White | Plano | Texas | 75093 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Providence Medical Research Group | Spokane | Washington | 99204 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| FG001 | 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
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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Amplatzer Post-Infarct Muscular VSCD Occluder Humanitarian Device Exemption Post-Approval Study | 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
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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). | Mean | Standard Deviation | years |
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| Sex: Female, Male | The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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. | Count of Participants | Participants |
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| Race (NIH/OMB) | 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. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Location of MI | The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). | Count of Participants | Participants |
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| Weight (kg) | 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. | Mean | Standard Deviation | kg |
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| Height (cm) | The PIVSD post-approval study composed of 2 cohorts including Cohort 1 (n=99) and Cohort 2 (n=32). | Mean | Standard Deviation | cm |
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| BMI | 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. | Mean | Standard Deviation | kg/m^2 |
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| Medical History | 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. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | End of Implant Procedure |
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| Primary | 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. | 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. | Posted | Count of Participants | Participants | Up to 7 days post-procedure |
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| Primary | Effectiveness Endpoint 3: Chronic Closure | Chronic closure is defined as the absence of a residual shunt ≥3 mm at 6 months or later. | 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. | Posted | Count of Participants | Participants | 6 months or later following a PIVSD device implant through study completion, an average of 1 year |
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| Primary | Safety Endpoint 1: Acute Survival | Acute survival is defined as survival for at least 24 hours following an attempted PIVSD device implant. | 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. | Posted | Count of Participants | Participants | Equal to or greater than 24 hours following an attempted PIVSD device implant through study completion, up to 9.7 years post-procedure |
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| Primary | Safety Endpoint 2: Chronic Survival | Chronic survival is defined as survival for at least 183 days from the time of first successful implant. | 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). | Posted | Number | 95% Confidence Interval | percentage of participants | Equal to or greater than 183 days from the time of first successful implant through study completion, up to 9.7 years post-procedure |
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Data in this study were collected retrospectively; therefore, no adverse event information was collected. Additionally, these data do not apply towards any of the study endpoints. Mortality data was collected to estimate survival through study completion, up to 9.7 years post-procedure.
Data in this study were collected retrospectively; therefore, no adverse event information was collected. Additionally, these data do not apply towards any of the study endpoints. Mortality data was collected to estimate survival through study completion, up to 9.7 years post-procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | 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. | 59 | 99 | 0 | 0 | 0 | 0 |
| EG001 | Cohort 2 | 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
Therefore, this cohort will be composed of retrospectively enrolled subjects. This cohort will be utilized to determine acute and chronic closure and chronic survival. | 16 | 32 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney Weiler | Abbott Medical Device | 224 430 4918 | ClinicalTrials.gov_SH_Inquiries@abbott.com |
| Sep 30, 2022 |
| Prot_SAP_000.pdf |
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| Male |
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| Cohort 2 |
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| More than one race |
| Unknown or Not Reported |
| Cohort 2 |
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| Posterior/Inferior (RCA) |
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| Lateral (Cicumflex) |
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| Unknown |
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| Cohort 2 |
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| Cohort 2 - Diabetes |
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| Cohort 2 - Hyperlipidemia |
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| Cohort 2 - History of Smoking |
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