Iatrogenic Atrial Septal Defect Study (iASD)

NCT ID: NCT04395027

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-06
• Study Completion Date: 2022-03-22

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.

Conditions

Septal Defect, Atrial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual care

These patients will not have their iatrogenic septal defect closed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Device

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

Group Type: EXPERIMENTAL

atrial septal defect closure

Intervention Type: DEVICE

The iatrogenic septal defect will be closed in the usual manner

Interventions

atrial septal defect closure

The iatrogenic septal defect will be closed in the usual manner

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Tiberio Frisoli

Senior Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marvin Eng, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital

Locations

Marvin Eng

Detroit, Michigan, United States

Countries

United States

Other Identifiers

13708

Identifier Type: -

Identifier Source: org_study_id