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HEAL-LAA Clinical Trial
NA trial testing WATCHMAN FLX Pro LAAC Device in Atrial Fibrillation in 949 participants. Completed in 18 September 2025.
| Lead sponsor | Boston Scientific Corporation |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 949 |
| Start date | 3 October 2023 |
| Primary completion | 15 July 2024 |
| Estimated completion | 18 September 2025 |
| Sites | 45 locations across United States |
Boston Scientific Corporation — full company profile →
18 and older, any sex, with Atrial Fibrillation or Bleeding. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incomplete seal with peri-device gap \> 5mm in the primary analysis subset implanted patients with 45-day TEE imaging (as assessed by the core lab).
| Group | Value | 95% CI |
|---|---|---|
| Primary Analysis Subset | 0 |
Composite CEC-adjudicated all-cause mortality, all stroke, systemic embolism, and major bleeding in the Intention to Treat (ITT) population at 6 months.
| Group | Value | 95% CI |
|---|---|---|
| Primary Analysis Subset | 54 |
Time frame: Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Primary Analysis Subset |
|---|---|---|
| Atrial fibrillation | Cardiac disorders | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Cardiac failure acute | Cardiac disorders | — |
| Cardiac failure congestive | Cardiac disorders | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Pneumonia | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Cerebrovascular accident | Nervous system disorders | — |
| Cellulitis | Infections and infestations | — |
| Hypotension | Vascular disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Coronary artery disease | Cardiac disorders | — |
| Colitis | Gastrointestinal disorders | — |
| Death | General disorders | — |
| Haemorrhage intracranial | Nervous system disorders | — |
| Iron deficiency anaemia | Blood and lymphatic system disorders | — |
| Angina pectoris | Cardiac disorders | — |
| Sinus node dysfunction | Cardiac disorders | — |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Rectal haemorrhage | Gastrointestinal disorders | — |
| Small intestinal obstruction | Gastrointestinal disorders | — |
| Catheter site haemorrhage | General disorders | — |
| Bronchitis | Infections and infestations | — |
| Reaction | System | Primary Analysis Subset |
|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Contusion | Injury, poisoning and procedural complications | — |
| Haematoma | Vascular disorders | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Pericardial effusion | Cardiac disorders | — |
| Catheter site haemorrhage | General disorders | — |
| Device related thrombosis | General disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Haematuria | Renal and urinary disorders | — |
| Gingival bleeding | Gastrointestinal disorders | — |
| Catheter site pain | General disorders | — |
| Skin laceration | Injury, poisoning and procedural complications | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Blood loss anaemia | Blood and lymphatic system disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Rectal haemorrhage | Gastrointestinal disorders | — |
| Small intestinal haemorrhage | Gastrointestinal disorders | — |
| Catheter site bruise | General disorders | — |
| Catheter site haematoma | General disorders | — |
| Oedema peripheral | General disorders | — |
| Cystitis | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | — |
| Lip injury | Injury, poisoning and procedural complications | — |
| Procedural haemorrhage | Injury, poisoning and procedural complications | — |
| Skin abrasion | Injury, poisoning and procedural complications | — |
| Traumatic haematoma | Injury, poisoning and procedural complications | — |
| Occult blood positive | Investigations | — |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — |
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | — |
| Ecchymosis | Skin and subcutaneous tissue disorders | — |
| Haemorrhage | Vascular disorders | — |
| Scalp haematoma | Vascular disorders | — |
Most-reported serious reactions: Atrial fibrillation, Gastrointestinal haemorrhage, Cardiac failure acute, Cardiac failure congestive, Acute respiratory failure, Acute kidney injury, Pneumonia, Urinary tract infection.
Data from ClinicalTrials.gov NCT05809596 adverse events section.
The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing