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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04395027
Study type Interventional
Source Henry Ford Health System
Contact
Status Withdrawn
Phase Phase 3
Start date May 6, 2020
Completion date March 22, 2022

See also
  Status Clinical Trial Phase
Completed NCT01711983 - Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects N/A
Enrolling by invitation NCT03373929 - Stitch Closure of PFO and Septal Repair N/A
Enrolling by invitation NCT05025475 - Stitch Closure of PFO and Septal Repair (STITCH) N/A
Completed NCT00581308 - Long-term Safety Study of the GORE® HELEX® Septal Occluder N/A