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Watchman FLX Pro CT Pilot Study
NA trial testing Left atrial appendage closure device WM FLX Pro in Non-valvular Atrial Fibrillation (AF) in 43 participants. Completed in 18 June 2025.
| Lead sponsor | Boston Scientific Corporation |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 43 |
| Start date | 24 March 2023 |
| Primary completion | 14 October 2024 |
| Estimated completion | 18 June 2025 |
| Sites | 1 location across Denmark |
Boston Scientific Corporation — full company profile →
Adults 18 to 90, any sex, with Non-valvular Atrial Fibrillation (AF). 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 | 3 | |
| 45 Days | 5 | |
| 3 Months | 5 |
Time frame: 12 Months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Device Arm |
|---|---|---|
| Atrial Fibrillation | Cardiac disorders | — |
| Pneumonia | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Iron deficiency anaemia | Blood and lymphatic system disorders | — |
| Cardiac Failure | Cardiac disorders | — |
| Concussion | Injury, poisoning and procedural complications | — |
| Cerebrovascular accident | Nervous system disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Inguinal hernia | Gastrointestinal disorders | — |
| Rectal haemorrhage | Gastrointestinal disorders | — |
| Device related thrombosis | General disorders | — |
| Covid-19 | Infections and infestations | — |
| Influenza | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Urosepsis | Infections and infestations | — |
| Eye injury | Injury, poisoning and procedural complications | — |
| Pelvic fracture | Injury, poisoning and procedural complications | — |
| Rib fracture | Injury, poisoning and procedural complications | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Cerebral haemorrhage | Nervous system disorders | — |
| Reaction | System | Device Arm |
|---|---|---|
| Catheter site bleeding | General disorders | — |
| Device related thrombosis | General disorders | — |
| Device leakage | Product Issues | — |
| GI bleeding | Gastrointestinal disorders | — |
| Aphonia | Respiratory, thoracic and mediastinal disorders | — |
| Groin hematoma | Vascular disorders | — |
Most-reported serious reactions: Atrial Fibrillation, Pneumonia, Urinary tract infection, Iron deficiency anaemia, Cardiac Failure, Concussion, Cerebrovascular accident, Pleural effusion.
Data from ClinicalTrials.gov NCT05567172 adverse events section.
The primary objective of this study is to measure device tissue coverage post-implantation of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device (WATCHMAN FLX Pro) using the serial advanced imaging modalities of cardiac computed tomography (CT) and transesophageal echocardiography (TEE) and assess its relationship, if any, to clinical events.
3 peer-reviewed publications 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/NCT05567172.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing