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WATCHMAN FLX™ CT Study
NA trial testing Watchman FLX Device in The Focus of the Study is to Reduce the Risk of Stroke and Life-threatening Bleeding Events in Patients With Non-valvular Atrial Fibrillation in 25 participants. Completed in 23 January 2025.
| Lead sponsor | Boston Scientific Corporation |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 9 November 2022 |
| Primary completion | 30 May 2024 |
| Estimated completion | 23 January 2025 |
| Sites | 1 location across Denmark |
Boston Scientific Corporation — full company profile →
18 and older, any sex, with The Focus of the Study is to Reduce the Risk of Stroke and Life-threatening Bleeding Events in Patients With Non-valvular Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Serial measurement of any HAT on the surface of the device at 14 days, 45 days and 3 months post implant as assessed by core lab using CT imaging
| Group | Value | 95% CI |
|---|---|---|
| 14 Days | 5 | |
| 45 Days | 3 | |
| 3 Months | 2 |
Time frame: 1 Year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Device Arm |
|---|---|---|
| Pneumonia | Infections and infestations | — |
| Cerebral Haemorrhage | Nervous system disorders | — |
| Aortic Valve Incompetence | Cardiac disorders | — |
| Atrial Fibrillation | Cardiac disorders | — |
| Gastric Ulcer | Gastrointestinal disorders | — |
| Gastric Ulcer Haemorrhage | Gastrointestinal disorders | — |
| Urosepsis | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Graft Haemorrhage | Injury, poisoning and procedural complications | — |
| Subdural Haematoma | Injury, poisoning and procedural complications | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — |
| Metastases to Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Thyroid Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Renal Failure | Renal and urinary disorders | — |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — |
| Death | General disorders | — |
| Reaction | System | Device Arm |
|---|---|---|
| Device Related Thrombosis | General disorders | — |
| Catheter Site Haemorrhage | General disorders | — |
| Sedation | Nervous system disorders | — |
Most-reported serious reactions: Pneumonia, Cerebral Haemorrhage, Aortic Valve Incompetence, Atrial Fibrillation, Gastric Ulcer, Gastric Ulcer Haemorrhage, Urosepsis, Fall.
Data from ClinicalTrials.gov NCT05324371 adverse events section.
WATCHMAN FLX™ CT is a prospective, single-arm, single-center, post-market investigation to assess device tissue coverage in subjects with non-valvular atrial fibrillation (AF) who receive the WATCHMAN FLX device to reduce the risk of stroke. Serial advanced imaging modalities such as CT and TEE will be used.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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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/NCT05324371.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing