OPTION EMEA
Research type
Research Study
Full title
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation – Europe, Middle East and Africa (OPTION EMEA)
IRAS ID
371109
Contact name
John Paisey
Contact email
Sponsor organisation
Boston Scientific Corporation
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 3 days
Research summary
Atrial fibrillation (AF) is a common heart rhythm disorder in which the upper chambers of the heart beat irregularly. This irregular rhythm can cause symptoms such as palpitations, tiredness, or shortness of breath. It also increases the risk of stroke because blood can pool in a small pouch of the heart called the left atrial appendage (LAA), where clots may form.
Two established treatment options are used for patients with AF. The first is catheter ablation, a procedure that aims to restore a normal heart rhythm by creating small areas of controlled energy in the heart tissue. The second is left atrial appendage closure (LAAC), which seals the LAA to reduce the risk of stroke for patients who cannot take long-term blood‑thinning medication.
This study will evaluate the safety and effectiveness of performing both procedures together during the same visit. The ablation will be done using the FARAPULSE™ Pulsed Field Ablation (PFA) System, which uses a type of electrical energy designed to target heart tissue more selectively than traditional heat‑based ablation. Immediately after this, the WATCHMAN FLX™ Pro or WATCHMAN FLX™ device will be used to close the left atrial appendage.
The goal of the study is to understand whether combining these two treatments in one procedure is safe, practical, and beneficial for patients. Researchers will assess the success of restoring a normal heart rhythm, whether the left atrial appendage is effectively sealed, and whether any complications occur. Participants will be followed after the procedure to monitor their recovery and long‑term outcomes.
This research may help improve AF treatment by offering patients a streamlined, single‑session approach for rhythm control and stroke prevention.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
26/YH/0095
Date of REC Opinion
1 Jul 2026
REC opinion
Further Information Favourable Opinion