Using WATCHMAN FLX Device to Treat Atrial Fibrillation in Patients with GI Bleeding

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

This study is testing whether the WATCHMAN FLX device can safely help patients with atrial fibrillation and a history of gastrointestinal bleeding by comparing their results to those who didn't receive the device.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kansas City Heart Rhythm Research Foundation (Academic / other)
• Locations: 4 sites (Overland Park, Kansas and 3 other locations)
• Trial ID: NCT06052358 on ClinicalTrials.gov

What this trial studies

The GI-FLX Registry aims to create a comprehensive registry of patients with Atrial Fibrillation (AF) who have a history of gastrointestinal bleeding and are undergoing Left Atrial Appendage Closure (LAAC) with the WATCHMAN FLX device. This multi-center, non-randomized registry will enroll approximately 250 prospective patients and compare their outcomes to a historical cohort of 250 patients with AF and GI bleeding who did not receive LAAC. The study seeks to fill a significant gap in existing literature regarding the safety and efficacy of LAAC in this high-risk population, particularly focusing on long-term bleeding events and the need for antithrombotic therapy. By analyzing these outcomes, the registry aims to provide valuable insights for clinicians managing similar patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with Atrial Fibrillation and a history of gastrointestinal bleeding.

Not a fit: Patients who are pregnant or have other indications for anticoagulation therapy, such as deep vein thrombosis or pulmonary embolism, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment strategies for patients with Atrial Fibrillation who are at risk of gastrointestinal bleeding.

How similar studies have performed: This approach is novel as no prior studies have specifically evaluated the outcomes of patients with prior GI bleeding undergoing LAAC.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

* 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 this trial is running

Overland Park, Kansas and 3 other locations

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

Study contacts

• Principal investigator: Dhanunjaya Lakkireddy, MD — Kansas City Heart Rhythm Institute
• Study coordinator: Donita Atkins

Conditions Atrial Fibrillation; GI Bleeding