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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03165526
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date May 6, 2017
First Posted Date May 24, 2017
Last Update Posted Date December 15, 2021
Actual Study Start Date October 1, 2018
Actual Primary Completion Date November 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2020)
  • 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 Month Visit ]
    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 ]
    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 ]
    Chronic survival is defined as survival for at least 183 days from the time of first successful implant.
Original Primary Outcome Measures
 (submitted: May 22, 2017)
  • 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: Between 24 hours and 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 between 24 hours and 7 days post-procedure.
  • 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.
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
Official Title The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Post-Infarction Ventricular Septal Defect
Intervention 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.
Study Groups/Cohorts
  • 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.
    Intervention: 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.

    Intervention: Device: AMPLATZER™ Post-infarct Muscular VSD Occluder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 7, 2021)
32
Original Estimated Enrollment
 (submitted: May 22, 2017)
30
Actual Study Completion Date November 29, 2021
Actual Primary Completion Date November 29, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03165526
Other Study ID Numbers SJM-CIP-10191
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Abbott Medical Devices
Original Responsible Party Same as current
Current Study Sponsor Abbott Medical Devices
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Maren Wagner Sponsor GmbH
PRS Account Abbott Medical Devices
Verification Date December 2021