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

Description

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.

Conditions

Atrial Fibrillation, GI Bleeding

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Overland Park

Kansas City Heart Rhythm Institute - Roe Clinic, Overland Park, Kansas, United States, 66211

Overland Park

Overland Park Regional Medical Center, Overland Park, Kansas, United States, 66215

Kansas City

Research Medical Center Clinic, Kansas City, Missouri, United States, 64032

Kansas City

Research Medical Center, Kansas City, Missouri, United States, 64032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kansas City Heart Rhythm Research Foundation,

Dhanunjaya Lakkireddy, MD, PRINCIPAL_INVESTIGATOR, Kansas City Heart Rhythm Institute

Study Record Dates

2025-08