Iatrogenic Atrial Septal Defect Study (iASD)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Iatrogenic Atrial Septal Defect Study

Conditions
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Septal Defect, Atrial

Intervention / Treatment
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* Device: atrial septal defect closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mitral valve intervention, iatrogenic septal defect