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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03165526
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment
Post-Infarction Ventricular Septal Defect Device: AMPLATZER™ Post-infarct Muscular VSD 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 3.5 years.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




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: 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.

  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 or later.

  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165526


Contacts
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Contact: Cathy Sonmore 651-756-5582 cathy.sonmore@abbott.com
Contact: Jillian Kolles 612-499-4139 jillian.kolles@abbott.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Maren Wagner Sponsor GmbH
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03165526    
Other Study ID Numbers: SJM-CIP-10191
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Heart Septal Defects, Ventricular
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities