Clinical Trial

Concomitant PFA Bsaed PVI Plus LAAC

Study acronym: COCONUT_2
Not Yet Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-02.
Trial Details
NCT Number NCT07450755
Lead Sponsor Asklepios proresearch
Conditions Atrial Fibrillation (AF), Bleeding, Stroke
Enrollment 150 participants
Start Date 2026-03-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-12