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

Recruiting at 3 trial locations

Overseen By Donita Atkins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kansas City Heart Rhythm Research Foundation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Dhanunjaya Lakkireddy, MD

Principal Investigator

Kansas City Heart Rhythm Institute

Eligibility Criteria

Inclusion Criteria

You are an adult aged 18 or older, regardless of gender.

You are suffering from Atrial Fibrillation.

You are able to comprehend the study protocol and observe it for its entirety.

Treatment Details

Participant Groups

Group I: Patients with a history of AF and GI bleeding without LAAC Experimental Treatment 0 Interventions

This is a historical cohort of patients with AF and recurrent GI bleeding without LAAC.

Group II: Patients with a history of AF and GI bleeding who will undergo LAAC Experimental Treatment 1 Intervention

This is group of patients who will undergo LAAC with Watchman FLX device and have a history of AF and GI bleed.

Who Is Running the Clinical Trial?

Kansas City Heart Rhythm Research Foundation

Lead Sponsor

Trials

30

Recruited

14,000+

Texas Cardiac Arrythmia Institute, Austin, Texas

Collaborator

Trials

1

Recruited

500+

Centennial Medical Center, Nashville, Tennessee

Collaborator

Trials

1

Recruited

500+

Kansas City Heart Rhythm Institute, Overland Park, Kansas

Collaborator

Trials

1

Recruited

500+

Los Robles Health System, Los Robles, California

Collaborator

Trials

1

Recruited

500+