Iatrogenic Atrial Septal Defect Study (iASD)

  • STATUS
    Recruiting
  • participants needed
    210
  • sponsor
    Henry Ford Health System
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Updated on 16 February 2024
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regurgitation
septal defect
mitral regurgitation
atrial septal defect
closure of atrial septal defect

Summary

This is an open-label, randomized, controlled trial of iatrogenic atrial septal defect closure with the an atrial septal occluder versus usual care observation in patients post-mitral valve intervention requiring large bore transspetal access.

Description

This study is an open label, prospective, multicenter, non-randomized single-arm study to evaluate the safety and efficacy of the closing iatrogenic atrial septal defects in patients undergoing transcatheter mitral valve procedures using large sheaths.

A maximum of 5 Clinical Sites (referred to as "Sites" in the remainder of this document) in the U.S. Two hundred and ten patients will be enrolled in this study. The patients will randomized 1:2 device: control. The anticipated accrual rate is approximately 20 Subjects per month for a total accrual period of approximately 12-18 months.

Patients may be enrolled into the study provided all inclusion and no exclusion criteria are met as specified in Section 4. Subjects will be evaluated through hospital discharge and return for follow-up visits at 30 days, 6 months, and 12 months.

Details
Condition Atrial septal defect
Age 18years - 100years
Treatment atrial septal defect closure
Clinical Study IdentifierNCT04395027
SponsorHenry Ford Health System
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 18 at the time of informed consent signature
Capable of complying with Protocol requirements, including follow-up
An Informed Consent Form signed by Subject or legal representative
Patient has had successful reduction of mitral regurgitation to at most moderate regurgitation post-mitral-clip

Exclusion Criteria

Remaining mitral regurgitation of moderate-severe
Subject unable or unwilling to provide informed consent
Concomitant severe aortic valve disease
Dialysis
Pregnancy or intent to become pregnant
Life expectancy < 1 year
Active bleeding
Inability to follow up with 6-month timepoint due logistical concerns
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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