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NCT06052358 · ClinicalTrials.gov registry record
Left Atrial Appendage Closure With WATCHMAN FLX Device in Recurrent Gastrointestinal Bleeding: The GI-FLX Registry
A clinical trial, sponsored by Kansas City Heart Rhythm Research Foundation.
- Terminated
- Registry status
- 73
- Enrollment target
NCT06052358: Clinical Trial study, sponsored by Kansas City Heart Rhythm Research Foundation.
NCT06052358 is a clinical trial that was terminated before completion, run by Kansas City Heart Rhythm Research Foundation. The registered enrollment target is 73 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06052358 was terminated before completion, sponsored by Kansas City Heart Rhythm Research Foundation.
- TERMINATED
- Registry status
- 73 participants
- Enrollment target
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.
Primary Outcome
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
Interventions
- DEVICE LAAC with Watchman FLX device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2023-08-23 |
| Est. Completion | 2025-06-11 |
Why NCT06052358 stopped before completion
NCT06052358 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 73 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which LAAC with Watchman FLX device is the first listed.
NCT06052358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06052358 about?
NCT06052358 is a clinical study titled "Left Atrial Appendage Closure With WATCHMAN FLX Device in Recurrent Gastrointestinal Bleeding: The GI-FLX Registry". 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 Reg...
What is the current status of trial NCT06052358?
This trial is currently terminated. The enrollment target is 73 participants. The study started on 2023-08-23. Estimated completion is 2025-06-11.
What interventions are being tested in trial NCT06052358?
The interventions under investigation include: LAAC with Watchman FLX device (DEVICE).
Who is sponsoring clinical trial NCT06052358?
This trial is sponsored by Kansas City Heart Rhythm Research Foundation, which has 22 total clinical trials registered on ClinicalTrials.gov.
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