Iatrogenic Atrial Septal Defect Study (iASD)

Septal Defect, Atrial Clinical Trial

— iASD  

Official title:

Iatrogenic Atrial Septal Defect Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04395027
• Other study ID #: 13708
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 6, 2020
• Est. completion date: March 22, 2022

Study information

• Verified date: December 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 22, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Atrial
• Septal Defect, Atrial

Intervention

Device:
• atrial septal defect closure
The iatrogenic septal defect will be closed in the usual manner

Locations

Country	Name	City	State
United States	Marvin Eng	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival	Survival at 6 months	6 month
Secondary	survival	survival at 1 year	1 year
Secondary	Freedom from heart failure hospitalization	Heart failure hospitalizations at 1 year	1 year
Secondary	NYHA Functional Class	Symptom status at 1 year	1 year