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COCONUT Study Concomitant PVI and LAAC

Study acronym: COCONUT
StatusRecruiting
PhaseNot specified
Started2025-03-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 19, 2026 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-03-18
minor
Study Status, Contacts/Locations v2
Primary completion date2026-01-01→2026-04-01
Study sitesdetails revised at 1 of 1 site
2025-04-23
minor
Study Status v1
Re-verified, no change to tracked fields
2025-03-01
minor
Original filing
In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and registries.8 While PVI and LAAC are both conducted in the left atrium and share the same access route, a combined concomitant approach might be beneficial for patients but is not conventionally practiced. Due to significantly shorter procedures times and high safety profile PFA based catheter ablation may be advantageous for the combined approach of PVI and LAAC. We are performing a word-wide, retrospective, multicenter registry study focusing on patients with concomitant Farapulse PFA based PVI and LAAC (WATCHMAN Flx, Boston Scientific). To evaluate safety, efficacy and efficiency in a multicenter study the COCONUT study was conducted.
Trial Details
NCT Number NCT06861673
Lead Sponsor Asklepios proresearch
Conditions Atrial Fibrillation (AF)
Enrollment 60 participants
Start Date 2025-03-01
Primary Completion 2026-04-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-19