COCONUT Study Concomitant PVI and LAAC

Condition(s) studied

Investigational drug(s) / intervention(s)

Pulmonary vein isolation: concomitant PVI and LAAC

Study summary

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

Primary outcome measure(s)

• Safety — within 3 days
  Peri- and postprocedural complications: Rate of: pericardial tamponade, pericardial effusion, Venouse access site haematoma
• Efficacy — one year
  Sinus rhythm after one year

Trial sites (1)

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