Atrial Fibrillation Clinical Trial
— FADE-DRTOfficial title:
Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion
Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device.
Status | Recruiting |
Enrollment | 360 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | St. David's Medical Center | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Cardiac Arrhythmia Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of Stroke, Systemic Embolism, and Device-related Thrombosis | 1 year | ||
Primary | Incidence of Major Bleeding Events | 1 year | ||
Secondary | Incidence of Minor Bleeding Events | 1 year |
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