Left Atrial Appendage Closure With WATCHMAN FLX Device in Recurrent Gastrointestinal Bleeding: The GI-FLX Registry

Stopped early

Conditions studied: Atrial Fibrillation, GI Bleeding

In brief

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.

Key facts

Study ID

NCT06052358

Run by

Kansas City Heart Rhythm Research Foundation

People needed

73

Starts

2023-08-23

Expected to finish

2025-06-11

Last updated by the study team

2025-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Kansas City Heart Rhythm Institute - Roe Clinic — Overland Park, Kansas, United States
• Overland Park Regional Medical Center — Overland Park, Kansas, United States
• Research Medical Center Clinic — Kansas City, Missouri, United States
• Research Medical Center — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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