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Patients with a history of AF and GI bleeding without LAAC for Atrial Fibrillation

N/A
Recruiting
Led By Dhanunjaya Lakkireddy, MD
Research Sponsored by Kansas City Heart Rhythm Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

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.

Eligible Conditions
  • Atrial Fibrillation
  • Gastrointestinal Bleeding

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with Primary systemic thromboembolism (STE)/stroke, Recurrent bleeding after initial period of oral anticoagulant (OAC) requiring blood transfusion or hospitalization and Hemorrhagic stroke
Secondary study objectives
Number of days or hours of Hospital stay
Number of participants with complications such as Peri-device leaks (PDL), Device related thrombosis (DRT), Minor bleeding episodes leading to hospital visit but no transfusion, Incidence of hospitalization and Mortality

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patients with a history of AF and GI bleeding without LAACExperimental Treatment0 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 LAACExperimental Treatment1 Intervention
This is group of patients who will undergo LAAC with Watchman FLX device and have a history of AF and GI bleed.

Find a Location

Who is running the clinical trial?

Texas Cardiac Arrythmia Institute, Austin, TexasUNKNOWN
Centennial Medical Center, Nashville, TennesseeUNKNOWN
Kansas City Heart Rhythm Institute, Overland Park, KansasUNKNOWN
~217 spots leftby Aug 2025
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