Iatrogenic Atrial Septal Defect Study (iASD)

Withdrawn before enrolling · Phase 3

Conditions studied: Septal Defect, Atrial

In brief

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.

Key facts

Study ID

NCT04395027

Run by

Henry Ford Health System

People needed

0

Starts

2020-05-06

Expected to finish

2022-03-22

Last updated by the study team

2022-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Marvin Eng — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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