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

Last updated: October 14, 2024
Sponsor: Kansas City Heart Rhythm Research Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcers

Chest Pain

Hemorrhage

Treatment

LAAC with Watchman FLX device

Clinical Study ID

NCT06052358
KCHRRF_GI FLX_0022
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ORemergency room visit requiring stopping of OAC OR outpatient 2 gm of Hgb drop frombaseline, with or without evidence of upper or lower GI bleeding and requiringendoscopic procedure with holding of OAC.

  • Ability to understand study procedures and to comply with them for the entire lengthof the study.

Exclusion

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 checkingurine beta-HCG).

  • Patient not following up with our practice / clinic after the procedure

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: LAAC with Watchman FLX device
Phase:
Study Start date:
August 23, 2023
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • Kansas City Heart Rhythm Institute - Roe Clinic

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • Overland Park Regional Medical Center

    Overland Park, Kansas 66215
    United States

    Active - Recruiting

  • Research Medical Center

    Kansas City, Missouri 64032
    United States

    Active - Recruiting

  • Research Medical Center Clinic

    Kansas City, Missouri 64032
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.