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Concomitant PFA Bsaed PVI Plus LAAC
Sponsor: Asklepios proresearch
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.
Official title: Pulse Field Ablation Based Pulmonary Vein Isolation Concomitant With Left Atrial Appendage Closure - The COCONUT II Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-03-01
Completion Date
2027-12-31
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Interventional LAA Closure
LAA Closure to prevent stroke and bleeding
Pulmonary vein isolation
Pulmonary vein isolation for atrial firbrillation treatment