Iatrogenic Atrial Septal Defect Study (iASD) (iASD)
Primary Purpose
Septal Defect, Atrial
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
atrial septal defect closure
Sponsored by
About this trial
This is an interventional treatment trial for Septal Defect, Atrial focused on measuring mitral valve intervention, iatrogenic septal defect
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 at the time of informed consent signature.
- Capable of complying with Protocol requirements, including follow-up.
- An Informed Consent Form signed by Subject or legal representative.
- Patient has had successful reduction of mitral regurgitation to at most moderate regurgitation post-mitral-clip.
Exclusion Criteria:
- Remaining mitral regurgitation of ≥ moderate-severe
- Subject unable or unwilling to provide informed consent
- Concomitant severe aortic valve disease
- Dialysis
- Pregnancy or intent to become pregnant
- Life expectancy < 1 year
- Active bleeding
- Inability to follow up with 6-month timepoint due logistical concerns
Sites / Locations
- Marvin Eng
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual care
Device
Arm Description
These patients will not have their iatrogenic septal defect closed.
These patients will have their iatrogenic septal defect closed after the mitral intervention is completed.
Outcomes
Primary Outcome Measures
survival
Survival at 6 months
Secondary Outcome Measures
survival
survival at 1 year
Freedom from heart failure hospitalization
Heart failure hospitalizations at 1 year
NYHA Functional Class
Symptom status at 1 year
Full Information
NCT ID
NCT04395027
First Posted
May 15, 2020
Last Updated
December 6, 2022
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT04395027
Brief Title
Iatrogenic Atrial Septal Defect Study (iASD)
Acronym
iASD
Official Title
Iatrogenic Atrial Septal Defect Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Administratively closed with IRB
Study Start Date
May 6, 2020 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
March 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septal Defect, Atrial
Keywords
mitral valve intervention, iatrogenic septal defect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
These patients will not have their iatrogenic septal defect closed.
Arm Title
Device
Arm Type
Experimental
Arm Description
These patients will have their iatrogenic septal defect closed after the mitral intervention is completed.
Intervention Type
Device
Intervention Name(s)
atrial septal defect closure
Intervention Description
The iatrogenic septal defect will be closed in the usual manner
Primary Outcome Measure Information:
Title
survival
Description
Survival at 6 months
Time Frame
6 month
Secondary Outcome Measure Information:
Title
survival
Description
survival at 1 year
Time Frame
1 year
Title
Freedom from heart failure hospitalization
Description
Heart failure hospitalizations at 1 year
Time Frame
1 year
Title
NYHA Functional Class
Description
Symptom status at 1 year
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 at the time of informed consent signature.
Capable of complying with Protocol requirements, including follow-up.
An Informed Consent Form signed by Subject or legal representative.
Patient has had successful reduction of mitral regurgitation to at most moderate regurgitation post-mitral-clip.
Exclusion Criteria:
Remaining mitral regurgitation of ≥ moderate-severe
Subject unable or unwilling to provide informed consent
Concomitant severe aortic valve disease
Dialysis
Pregnancy or intent to become pregnant
Life expectancy < 1 year
Active bleeding
Inability to follow up with 6-month timepoint due logistical concerns
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marvin Eng, MD
Organizational Affiliation
Henry Ford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marvin Eng
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Iatrogenic Atrial Septal Defect Study (iASD)
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