Concomitant PFA Bsaed PVI Plus LAAC

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsklepios proresearch

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

Treatment groups

150 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators