NCT07450755

Concomitant PFA Bsaed PVI Plus LAAC

Pulse Field Ablation Based Pulmonary Vein Isolation Concomitant With Left Atrial Appendage Closure - The COCONUT II Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Asklepios proresearch · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective is to invite high-volume centers in Germany to submit the procedural and periprocedural data, as well as the 12-months follow-up data in a secure and standardized way. In comparison to the most registries conducted today, a dedicated database comprising a standardized questionnaire, as well as multiple data validation processes 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 concomitant PFA based PVI and LAAC approach to treat AF and prevent bleeding and stroke within 12 months. Furthermore, economic factors could be beneficial due to only one concomitant procedure with one hospital stay instead of two procedures with two hospital stays.

Conditions

• Atrial Fibrillation (AF)
• Bleeding
• Stroke

Interventions

Type	Name	Description
PROCEDURE	Interventional LAA Closure	LAA Closure to prevent stroke and bleeding
PROCEDURE	Pulmonary vein isolation	Pulmonary vein isolation for atrial firbrillation treatment

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2026-03-05
• Last updated: 2026-03-12