Iatrogenic Atrial Septal Defect Study (iASD)

Henry Ford Health

Status and phase: Withdrawn; Phase 3

Conditions: Septal Defect, Atrial

Treatments: Device: atrial septal defect closure

Study type: Interventional

Funder types: Other

Identifiers

NCT04395027

13708

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Remaining mitral regurgitation of ≥ moderate-severe
2. Subject unable or unwilling to provide informed consent
3. Concomitant severe aortic valve disease
4. Dialysis
5. Pregnancy or intent to become pregnant
6. Life expectancy < 1 year
7. Active bleeding
8. Inability to follow up with 6-month timepoint due logistical concerns

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Usual care

No Intervention group

Description:

These patients will not have their iatrogenic septal defect closed.

Device

Experimental group

Description:

These patients will have their iatrogenic septal defect closed after the mitral intervention is completed.

Treatment:

Device: atrial septal defect closure