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NCT07450755Not yet recruiting

Concomitant PFA Bsaed PVI Plus LAAC

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

Source: ClinicalTrials.gov · Last updated 12 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
150 (estimated)
First submitted
17 Feb 2026
Start date
1 Mar 2026
Primary completion date
31 Dec 2026
Lead sponsor
Asklepios proresearch
NCT number
NCT07450755

What you commit to

  • Study type: Interventional
  • Planned participants: 150
  • From 1 Mar 2026 to the primary completion date, 31 Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous catheter ablation for AF

Other

  • Contraindications for PVI and / or LAA closure
  • Pregnancy

Who the study is looking for

  • Age ≥ 18 years
  • Willing to participate
  • Atrial fibrillation and indication for PVI (ESC guideline 2024)
  • Indication for OAC therapy (CHA2DS2VA score \>/=2)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.