CI

At a glance

ClinicalIndex Comparison Record
N/ATerminated· 73 enrolled
Drug / intervention
LAAC with Watchman FLX devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06052358
NCT06052358N/ATerminated
Terminated

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

Kansas City Heart Rhythm Research Foundation·observational·Posted Sep 25, 2023·Updated Sep 4, 2025

In Brief

An observational study evaluating LAAC with Watchman FLX device for Atrial Fibrillation and GI Bleeding. Terminated early, enrolled 73 participants across 4 sites.

Signals

Trial was terminated early

Detailed 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.

Study Details

Timeline

N/ATerminatedFinished
202420252026
First PostedSep 25, 2023
Enrollment StartAug 23, 2023
Primary CompletionJun 11, 2025
TodayJul 1, 2026
Enrollment to primary: 1.8 yearsPosted 2.8 years ago

Interventions

LAAC with Watchman FLX devicedevice

LAAC with Watchman FLX device