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

Recruiting

• Conditions: Atrial Fibrillation; GI Bleeding
• Interventions: Device: LAAC with Watchman FLX device

• Registration Number: NCT06052358
• Lead Sponsor: Kansas City Heart Rhythm Research Foundation

Brief 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.

Detailed Description

A large gap in the literature exists as no prior study has evaluated the outcomes of those with prior GI bleeding undergoing LAAC. Furthermore, patients with prior GI bleed may be on no or minimal antithrombotic therapy prior to LAAC and subsequently require escalation of antithrombotic therapy following LAAC. Long-term outcomes including bleeding events will be most relevant and informative to this potentially high-risk subgroup. Therefore, this is an attempt to create a prospective registry describing outcomes of patients with AF and prior GI bleed undergoing LAAC to provide insight into safety and efficacy and will also compare to a historical cohort of patients with AF and GI bleed without LAAC.

Study Timeline

• Study Start: 2023-08-23
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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	12 Months	Baseline characteristics of participants such as Primary systemic thromboembolism (STE)/stroke, Recurrent bleeding after initial period of oral anticoagulant (OAC) requiring blood transfusion or hospitalization and Hemorrhagic stroke will be evaluated

Secondary Outcome Measures

Name	Time	Method
Number of days or hours of Hospital stay	45 Days, 6 Months and 12 Months	If any participants are hospitalized, their Hospital length of stay will be evaluated.
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	45 Days, 6 Months and 12 Months	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 will be evaluated.

Trial Locations

Locations (4)

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

Kansas City Heart Rhythm Institute - Roe Clinic; 🇺🇸 Overland Park, Kansas, United States