Left Atrial Appendage Closure With WATCHMAN FLX Device in Recurrent Gastrointestinal Bleeding: The GI-FLX Registry
Key facts
- Who runs it
- Kansas City Heart Rhythm Research Foundation
- Where
- Kansas City and Overland Park, United StatesSee the 4 sites
- Trial code
- Status
- Terminated
- People taking part
- 73 people enrolled
- Started
- 23 Aug 2023
- Ended
- 11 Jun 2025
- Type of study
- Observational, 2 groups
- Treatments tested
- LAAC with Watchman FLX device
- Record updated
- 4 September 2025
- Why it stopped
- The study has been closed by the Sponsor.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Other indications for OAC like deep vein thrombosis (DVT) or Pulmonary embolism (PE) or mechanical heart valve
- Inability or unwillingness of individual to give written informed consent
- 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
Where in United States
- Research Medical CenterKansas City, United States
- Research Medical Center ClinicKansas City, United States
- Kansas City Heart Rhythm Institute - Roe ClinicOverland Park, United States
- Overland Park Regional Medical CenterOverland Park, United States
About the trial
What the trial wants to find out
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 WATCHMAN FLX device and compare to patients with AF and GI bleed who do not have LAAC. The GI-FLX Registry will be a multi-center, non-randomized registry. Approximately 250 prospective patients will be enrolled at all 4 sites. Historical cohort of 250 patients after propensity score matching with WATCHMAN-FLX arm will be included in the final analysis.
The 2 groups in the trial
- Patients with a history of AF and GI bleeding who will undergo LAAC
This is group of patients who will undergo LAAC with Watchman FLX device and have a history of AF and GI bleed.
Treatment: LAAC with Watchman FLX device
- Patients with a history of AF and GI bleeding without LAAC
This is a historical cohort of patients with AF and recurrent GI bleeding without LAAC.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 4 September 2025