Boston Scientific has launched the OPTION clinical trial of its next-generation WATCHMAN FLX left atrial appendage closure (LAAC) device to minimise stroke risk in patients having non-valvular atrial fibrillation (AF) and receive a cardiac ablation procedure.
WATCHMAN is a permanent implant for closing the left atrial appendage in the heart to mitigate the stroke risk.
The new device has a fully enclosed and rounded frame to enable implantation flexibility for customising the placement. Physicians will be able to fully recapture and reposition the device during a procedure.
During the randomised, controlled OPTION trial, the safety and effectiveness of the new WATCHMAN FLX implant will be compared to first-line oral anticoagulants (OAC) such as direct oral anticoagulants (DOAC) and warfarin.
At 130 worldwide sites, the study will recruit 1,600 non-valvular AF patients who are suitable for OAC therapy and have recently had or will undergo an ablation.
Primary effectiveness endpoint of the trial is all cause death, stroke and systemic embolism through 36 months, while the primary safety endpoint will be measured as non-procedural bleeding through 36 months.
OPTION trial principal investigator Oussama Wazni said: “Cardiac ablation is an effective way to treat an abnormal heart rhythm for many patients, though symptomatic relief can lead these patients to stop taking their blood thinners and unknowingly put themselves at an elevated risk for a stroke.
“This first-of-its-kind trial will explore whether the one-time WATCHMAN FLX device could replace commonly used anticoagulants for long-term stroke risk reduction in this growing patient population.”
Boston Scientific executive vice-president and global chief medical officer Ian Meredith said that the trial data could support the use of the LAAC device as an alternative to anticoagulants.
The device secured the European CE-Mark in March this year.