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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 is a clinical trial that was terminated before completion, run by Kansas City Heart Rhythm Research Foundation. The registered enrollment target is 73 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06052358
The ClinicalTrials.gov registry entry for NCT06052358 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kansas City Heart Rhythm Research Foundation, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LAAC with Watchman FLX device is the first listed.
NCT06052358 reports 0 study locations.
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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