Status:
UNKNOWN
RF Applications for Residual LAA Leaks
Lead Sponsor:
Texas Cardiac Arrhythmia Research Foundation
Conditions:
Left Atrial Appendage Thrombosis
Stroke, Ischemic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Although the clinical impact of residual left atrial appendage (LAA) leaks still requires confirmation, its patency resulting from incomplete LAA closure may promote blood stagnation and thrombus form...
Detailed Description
Therapies locally targeting the LAA via occlusion, exclusion, or excision have emerged as an alternative and effective approach for stroke prophylaxis in AF patients, especially those with OAC contra-...
Eligibility Criteria
Inclusion
- Age\> 18 years.
- Presence of a significant LAA leak acutely or at follow-up.
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
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 :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04726943
Start Date
February 1 2021
End Date
December 31 2022
Last Update
February 11 2021
Active Locations (2)
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1
Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States, 66615
2
St. David's Medical Center
Austin, Texas, United States, 78723