Septal Defect, Atrial
Conditions
Keywords
mitral valve intervention, iatrogenic septal defect
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.
Interventions
DEVICEatrial septal defect closure
The iatrogenic septal defect will be closed in the usual manner
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| survival | 6 month | Survival at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| survival | 1 year | survival at 1 year |
| Freedom from heart failure hospitalization | 1 year | Heart failure hospitalizations at 1 year |
| NYHA Functional Class | 1 year | Symptom status at 1 year |
Countries
United States
Outcome results
None listed