About this trial
In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and registries.8 While PVI and LAAC are both conducted in the left atrium and share the same access route, a combined concomitant approach might be beneficial for patients but is not conventionally practiced. Due to significantly shorter procedures times and high safety profile PFA based catheter ablation may be advantageous for the combined approach of PVI and LAAC. We are performing a word-wide, retrospective, multicenter registry study focusing on patients with concomitant Farapulse PFA based PVI and LAAC (WATCHMAN Flx, Boston Scientific). To evaluate safety, efficacy and efficiency in a multicenter study the COCONUT study was conducted.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients with AF and PVI plus LAAC
Trial design
Cohort
Other
Treatments tested in this trial
Pulmonary vein isolation
Deviceconcomitant PVI and LAAC
Treatment groups
Trial outcomes
Primary outcomes
Safety
Peri- and postprocedural complications: Rate of: pericardial tamponade, pericardial effusion, Venouse access site haematoma
Efficacy
Sinus rhythm after one year
Sponsors and contacts
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