Iatrogenic Atrial Septal Defect Study (iASD)

Phase 3

Withdrawn

• Conditions: Septal Defect, Atrial
• Interventions: Device: atrial septal defect closure

• Registration Number: NCT04395027
• Lead Sponsor: Henry Ford Health System

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 intervention requiring large bore transspetal access.

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 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.

Study Timeline

• Study Start: 2020-05-06
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-20
• Primary Completion: 2022-03-22
• Study Completion: 2022-03-22
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device	atrial septal defect closure	These patients will have their iatrogenic septal defect closed after the mitral intervention is completed.

Primary Outcome Measures

Name	Time	Method
survival	6 month	Survival at 6 months

Secondary Outcome Measures

Name	Time	Method
survival	1 year	survival at 1 year
NYHA Functional Class	1 year	Symptom status at 1 year
Freedom from heart failure hospitalization	1 year	Heart failure hospitalizations at 1 year

Trial Locations

Locations (1)

Marvin Eng; 🇺🇸 Detroit, Michigan, United States