ELAPSE
Research type
Research Study
Full title
Early closure of Left atrial Appendage for Patients with atrial fibrillation and ischemic StrokE despite anticoagulation therapy – ELAPSE
IRAS ID
347762
Contact name
Lorenz Räber
Contact email
Sponsor organisation
Insel Gruppe AG
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
SNCTP000005973, Swiss National Clinical Trial Portal
Duration of Study in the UK
3 years, 9 months, 0 days
Research summary
Atrial fibrillation (AF) is one of the most common heart rhythm disorders, significantly increasing the risk of cardioembolic stroke. The use of direct oral anticoagulants (DOACs) is employed to reduce this risk. Despite DOAC therapy, a residual annual stroke risk of 1-2% remains. It was found, according to the Swiss Stroke Registry, that 38% of AF patients who experienced an ischemic stroke were already on anticoagulant therapy. In a previous study, it was observed that AF patients who suffered an ischemic stroke despite anticoagulation were at a higher risk of experiencing another stroke.
Data from 11 international stroke centers were analyzed, revealing that 76% of these strokes were due to "breakthrough" cardioembolism, while 24% were caused by other factors unrelated to AF. Two observational studies, including over 4000 patients, were conducted but did not identify any secondary prevention strategy (such as switching DOACs or adding antiplatelet therapy) that was clearly superior.
Inspired by a recent randomized controlled trial suggesting that surgical occlusion of the left atrial appendage (LAAO) might provide additional protection against strokes when combined with anticoagulation, a retrospective study was performed. It was found that combining LAAO with DOAC therapy reduced adverse outcomes compared to DOAC therapy alone.
It is hypothesized that for AF patients who have had a stroke despite anticoagulation, combining LAAO with DOAC therapy will be more effective than DOAC therapy alone. This hypothesis will be tested by evaluating whether this combined approach reduces the risk of recurrent strokes, systemic embolism, and cardiovascular death.In a multicenter, randomized controlled trial, patients will be randomly assigned to receive either LAAO plus DOAC therapy or DOAC therapy alone. The LAAO procedure will be performed by experienced operators using FDA/CE approved devices. Follow-up visits will include a hospital visit at 1-3 months post-procedure (for the LAAO group) and phone interviews every six months for all patients, starting six months after randomization.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/LO/0488
Date of REC Opinion
2 Sep 2025
REC opinion
Further Information Favourable Opinion