Post-Infarction Ventricular Septal DefectPIVSD PASNCT03165526
The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
An observational study of Post-Infarction Ventricular Septal Defect, run by Abbott Medical Devices at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Infarction Ventricular Septal Defect
- What is being tested?
- AMPLATZER™ Post-infarct Muscular VSD Occluder
- Type of treatment
- Medical device
- How many people
- 131 participants
- Where
- 17 sitesUnited States
- Study dates
- 1 Oct 2018to 29 Nov 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Johns Hopkins University Hospital
Baltimore, Maryland, 21287
Buffalo General Hospital
Buffalo, New York, 14203
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Good Samaritan Trihealth Hospital
Cincinnati, Ohio, 45220
Duke University
Durham, North Carolina, 27710
Shands at the University of Florida
Gainesville, Florida, 32610
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, 49503
UNC Regional Physicians Carolina Cardiology
High Point, North Carolina, 27262
Memorial Hermann Hospital
Houston, Texas, 77030
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Marshfield Clinic
Marshfield, Wisconsin, 54449
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
Lenox Hill Hospital
New York, New York, 10021
Baylor Scott & White
Plano, Texas, 75093
University of California at San Francisco
San Francisco, California, 94143
Swedish Medical Center
Seattle, Washington, 98122
Providence Medical Research Group
Spokane, Washington, 99204
About this study
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.
Read the 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.
- Being tested
- AMPLATZER™ Post-infarct Muscular VSD Occluder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPLATZER™ Post-infarct Muscular VSD OccluderDevice
The AMPLATZER™ PIVSD Occluder is intended for percutaneous transcatheter closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AMPLATZER™ Post-infarct Muscular VSD Occluder | |
| 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. Receives: Device: AMPLATZER™ Post-infarct Muscular VSD Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Equal to or greater than 183 days from the time of first successful implant through study completion, up to 9.7 years post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Oct 2018
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Infarction Ventricular Septal DefectStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Palmer, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165526
- Sponsor's protocol ID
- SJM-CIP-10191
- Acronym
- PIVSD PAS
- Status last verified
- Jul 2024
- First submitted
- 6 May 2017
- Last updated
- 10 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
- ClinicalTrials.gov ID
- NCT03165526
- Acronym / sponsor ID
- PIVSD PAS / SJM-CIP-10191
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 4 years. The total duration of the clinical study is expected to be 4.5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Cohort | – | Device: AMPLATZER™ Post-infarct Muscular VSD OccluderAll 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. |
| Second Cohort | – | Device: AMPLATZER™ Post-infarct Muscular VSD OccluderThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMPLATZER™ Post-infarct Muscular VSD OccluderThe AMPLATZER™ PIVSD Occluder is intended for percutaneous transcatheter closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates. | Device | First Cohort, Second Cohort |
Primary outcome
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.
Effectiveness Endpoint 2: Acute Closure
Time frame: Up to 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 immediately after the successful deployment of the device and up to 7 days post-procedure.
Effectiveness Endpoint 3: Chronic Closure
Time frame: 6 months or later following a PIVSD device implant through study completion, an average of 1 year
Chronic closure is defined as the absence of a residual shunt ≥3 mm at 6 months or later.
Safety Endpoint 1: Acute Survival
Time frame: Equal to or greater than 24 hours following an attempted PIVSD device implant through study completion, up to 9.7 years post-procedure
Acute survival is defined as survival for at least 24 hours following an attempted PIVSD device implant.
Safety Endpoint 2: Chronic Survival
Time frame: Equal to or greater than 183 days from the time of first successful implant through study completion, up to 9.7 years post-procedure
Chronic survival is defined as survival for at least 183 days from the time of first successful implant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Palmer study director
Sponsor GmbH
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Infarction Ventricular Septal Defect, run by Abbott Medical Devices at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness Endpoint 1: Technical Success (time frame: End of Implant Procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.