NCT04395027

Iatrogenic Atrial Septal Defect Study (iASD)

Iatrogenic Atrial Septal Defect Study

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septal Defect, Atrial

Interventions

Type	Name	Description
DEVICE	atrial septal defect closure	The iatrogenic septal defect will be closed in the usual manner

Timeline

• Start date: 2020-05-06
• Primary completion: 2022-03-22
• Completion: 2022-03-22
• First posted: 2020-05-20
• Last updated: 2022-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study