Status:
UNKNOWN
Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion
Lead Sponsor:
Texas Cardiac Arrhythmia Research Foundation
Conditions:
Device-Related Thrombosis
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device.
Detailed Description
Data on the optimal antithrombotic therapy (AT) after percutaneous left atrial appendage (LAA) occlusion are still scarce. The classical AT strategy after LAA occlusion includes 6-weeks of warfarin + ...
Eligibility Criteria
Inclusion
- Men and women ≥18 years of age
- Successful LAAC procedure (device implanted without procedural or bleeding complication).
- Patients contraindicated or unsuitable for long-term OAC.
- History of AF (permanent or persistent or paroxysmal).
- Written informed consent by the patient or designee if the patient is unable to consent
Exclusion
- Life expectancy \< 2 years.
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04502017
Start Date
August 5 2020
End Date
December 31 2023
Last Update
August 7 2020
Active Locations (1)
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1
St. David's Medical Center
Austin, Texas, United States, 78705