Iatrogenic Atrial Septal Defect Study (iASD) (iASD)

Iatrogenic Atrial Septal Defect Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Septal Defect, Atrial
• Intervention / Treatment: Device: atrial septal defect closure

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Marvin Eng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; These patients will not have their iatrogenic septal defect closed.
Experimental: Device; These patients will have their iatrogenic septal defect closed after the mitral intervention is completed.	Device: atrial septal defect closure; The iatrogenic septal defect will be closed in the usual manner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival	Survival at 6 months	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival	survival at 1 year	1 year
Freedom from heart failure hospitalization	Heart failure hospitalizations at 1 year	1 year
NYHA Functional Class	Symptom status at 1 year	1 year

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Marvin Eng, MD, Henry Ford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2020
• Primary Completion (Actual): March 22, 2022
• Study Completion (Actual): March 22, 2022

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: mitral valve intervention; iatrogenic septal defect
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Heart Septal Defects, Atrial
• Other Study ID Numbers: 13708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No