About this trial
A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy and efficiency of this approach (COCONUT II study). If available the transseptal puncture will be performed by the VersaCross System (Boston scientific). If already available LAAC procedure will be performed utilizing the Watchman Flx pro device (Boston scientific) or the Watchman Flx device (Boston scientific).
For procedure planning, assessment of the LAA size and selection of the Watchman Flx device a preprocedural cardiac computed tomography in combination with the TruePLan Software is recommended.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Willing to participate
Atrial fibrillation and indication for PVI (ESC guideline 2024)
Indication for OAC therapy (CHA2DS2VA score >/=2)
Disqualifiers
Contraindications for PVI and / or LAA closure
Pregnancy
Previous catheter ablation for AF
Trial design
Treatments tested in this trial
- Interventional LAA Closure
- Pulmonary vein isolation