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

NCT06052358 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 73

Last updated 2025-09-04

No results posted yet for this 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.

Conditions

Interventions

DEVICE

LAAC with Watchman FLX device

LAAC with Watchman FLX device

Sponsors & Collaborators

  • Kansas City Heart Rhythm Research Foundation

    lead OTHER

  • Kansas City Heart Rhythm Institute, Overland Park, Kansas

    collaborator UNKNOWN

  • Texas Cardiac Arrythmia Institute, Austin, Texas

    collaborator UNKNOWN

  • Los Robles Health System, Los Robles, California

    collaborator UNKNOWN

  • Centennial Medical Center, Nashville, Tennessee

    collaborator UNKNOWN

Principal Investigators

  • Dhanunjaya Lakkireddy, MD · Kansas City Heart Rhythm Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-23
Primary Completion
2025-06-11
Completion
2025-06-11
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06052358 on ClinicalTrials.gov