Status:
WITHDRAWN
Iatrogenic Atrial Septal Defect Study (iASD)
Lead Sponsor:
Henry Ford Health System
Conditions:
Septal Defect, Atrial
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 interventi...
Detailed 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 transc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04395027
Start Date
May 6 2020
End Date
March 22 2022
Last Update
December 8 2022
Active Locations (1)
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1
Marvin Eng
Detroit, Michigan, United States, 48202