Status:
TERMINATED
Left Atrial Appendage Closure With WATCHMAN FLX Device in Recurrent Gastrointestinal Bleeding: The GI-FLX Registry
Lead Sponsor:
Kansas City Heart Rhythm Research Foundation
Collaborating Sponsors:
Kansas City Heart Rhythm Institute, Overland Park, Kansas
Texas Cardiac Arrythmia Institute, Austin, Texas
Conditions:
Atrial Fibrillation
GI Bleeding
Eligibility:
All Genders
18+ years
Brief Summary
The GI-FLX Registry is intended to create a registry of patients with a history of Atrial Fibrillation (AF) and Gastrointestinal (GI) bleed who will receive Left Atrial Appendage Closure (LAAC) with W...
Detailed Description
A large gap in the literature exists as no prior study has evaluated the outcomes of those with prior GI bleeding undergoing LAAC. Furthermore, patients with prior GI bleed may be on no or minimal ant...
Eligibility Criteria
Inclusion
- All male and female patients who are \> 18 years of age
- Have Atrial Fibrillation
- Have CHADS2VASc \> 2
- Have history of GI bleeding OR hospital admission that required blood transfusion OR emergency room visit requiring stopping of OAC OR outpatient 2 gm of Hgb drop from baseline, with or without evidence of upper or lower GI bleeding and requiring endoscopic procedure with holding of OAC.
- Ability to understand study procedures and to comply with them for the entire length of the study.
Exclusion
- Inability or unwillingness of individual to give written informed consent.
- Other indications for OAC like deep vein thrombosis (DVT) or Pulmonary embolism (PE) or mechanical heart valve.
- Patient who is pregnant will be excluded (Pregnancy will be excluded by checking urine beta-HCG).
- Patient not following up with our practice / clinic after the procedure
Key Trial Info
Start Date :
August 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 11 2025
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT06052358
Start Date
August 23 2023
End Date
June 11 2025
Last Update
September 4 2025
Active Locations (4)
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1
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, United States, 66211
2
Overland Park Regional Medical Center
Overland Park, Kansas, United States, 66215
3
Research Medical Center Clinic
Kansas City, Missouri, United States, 64032
4
Research Medical Center
Kansas City, Missouri, United States, 64032