Safety And Efficacy Study Of Transcatheter Closure Of Ostium Secundum ASDs
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-001458
NCT ID: NCT02985684
Sponsor Protocol Number: ASD 15-04
About this study
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Appropriate ASD anatomy.
- Note: Additional Inclusion Criteria may apply.
Exclusion Criteria:
- Absence of concurrent cardiac conditions that could elevate morbidity/mortality beyond what is common for ASD.
- Note: Additional Exclusion Criteria may apply.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Donald Hagler SR, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available