WATCH-Rhythm - Study number S2236, Protocol number 92373807
Research type
Research Study
Full title
WATCH-Rhythm (WATCHMAN for concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm)- WATCH-Rhythm (S2236-92373807
IRAS ID
268578
Contact name
Tom Wong
Contact email
Sponsor organisation
Boston Scientific International SA
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
3 years, 11 months, 2 days
Research summary
Atrial Fibrillation (AF) is the commonest heart rhythm disturbance. AF is often managed by performing a heart procedure called catheter ablation (applying high energy to burn tissue). This stops abnormal electrical activity from certain areas of the heart allowing the AF to change into normal (sinus) rhythm.
Unfortunately, in people with persistent AF (AF all the time), this can be difficult to achieve. Approximately half of the participants who have this procedure, are back in AF after 18 months.
The main aim of our research is to help the participants with AF remain in normal rhythm by changing the current way of doing AF ablation. Standard AF ablation targets four veins in the heart (pulmonary veins). The plan is to target an additional area in the heart: a pouch-like structure called the left atrial appendage (LAA). Studies have demonstrated that LAA ablation results in participants staying in a normal rhythm for longer.
Additionally, AF increases stroke risk. In AF, 90% of clots that cause a stroke, comes from the LAA. This is why lifelong anticoagulation (blood thinning medication) is needed for many people in AF participants. Therefore, after LAA ablation, a device will be implanted that closes the LAA. The benefit is that participants having an AF ablation procedure would no longer need anticoagulation to reduce their stroke risk.
For the first time, this study will directly compare participants undergoing standard AF ablation to those undergoing standard AF ablation with the addition of LAA ablation & LAA closure. 258 participants in persistent AF will be recruited and randomised equally (129 participants in each group). The study will take place in up to 15 hospitals worldwide, including the UK. The aim is to recruit over a two-year period and follow-up each participant for two years (total duration: four years).
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
20/WM/0062
Date of REC Opinion
12 May 2020
REC opinion
Further Information Favourable Opinion