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NCT06052358
Left Atrial Appendage Closure With WATCHMAN FLX Device in Recurrent Gastrointestinal Bleeding: The GI-FLX Registry
trial testing LAAC with Watchman FLX device in Atrial Fibrillation in 73 participants. Terminated before completion.
11 June 2025
Quick facts
| Lead sponsor | Kansas City Heart Rhythm Research Foundation |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 73 |
| Start date | 23 August 2023 |
| Primary completion | 11 June 2025 |
| Estimated completion | 11 June 2025 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- LAAC with Watchman FLX device
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
- GI Bleeding — all drugs for GI Bleeding →
Sponsor
Kansas City Heart Rhythm Research Foundation
Who can join
18 and older, any sex, with Atrial Fibrillation or GI Bleeding. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06052358
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Other Kansas City Heart Rhythm Research Foundation trials
Trials by the same sponsor.
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- NCT05826665 — Observational Study to Examine the Procedural and Outcomes of AF Ablation Assisted by STAR Apollo™ Mapping System · recruiting
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- NCT06061757 — Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure · NA · recruiting
- NCT04499807 — Accuracy of Rhythm Detection by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study) · NA · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06052358 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kansas City Heart Rhythm Research Foundation
- Last refreshed: 4 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06052358.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing