Concomitant PFA Bsaed PVI Plus LAAC
COCONUT_2
Pulse Field Ablation Based Pulmonary Vein Isolation Concomitant With Left Atrial Appendage Closure - The COCONUT II Study
1 other identifier
interventional
150
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedFirst Posted
Study publicly available on registry
March 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 12, 2026
March 1, 2026
10 months
February 17, 2026
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
• Primary safety endpoint: Major complications, (SAE) within 30 days
30 days
• Primary efficacy endpoint: Acute success of PVI and LAA closure
30 days
• Primary efficiency endpoint: Duration of hospital stay (nights) within 30 days
30 days
Study Arms (1)
Concomitant PVI plus LAAC
EXPERIMENTALInterventions
LAA Closure to prevent stroke and bleeding
Pulmonary vein isolation for atrial firbrillation treatment
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Willing to participate
- Atrial fibrillation and indication for PVI (ESC guideline 2024)
- Indication for OAC therapy (CHA2DS2VA score \>/=2)
You may not qualify if:
- Contraindications for PVI and / or LAA closure
- Pregnancy
- Previous catheter ablation for AF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
February 17, 2026
First Posted
March 5, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share