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Concomitant PFA Bsaed PVI Plus LAAC

Study acronym: COCONUT_2
StatusNot Yet Recruiting
PhaseNot applicable
Started2026-03-01
View on ClinicalTrials.gov ↗

Amendment history

2026-03-11
Study Identification, Study Status, Study Description, Arms and Interventions v1
InterventionsPVI plus LAAC (Device)→Interventional LAA Closure (Procedure), Pulmonary vein isolation (Procedure)
Study description-7 characters
OurThe objective is to invite high-volume centers in Germany to su [...] d way. In comparison to the most registries conducted today, we plan to use a dedicated database comprising a standardized questionnair [...] at different levels in order to assure a better data quality is used. The aim of the COCONUT II study will collect data of a con [...]
Study title-31 characters
Concomitant PFA Bsaed PVI Plus LAAC - a Prospective Registry Study
2026-03-02
Original filing
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.
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