Concomitant PFA Bsaed PVI Plus LAAC
Starting soon · Not applicable
Conditions studied: Atrial Fibrillation (AF), Bleeding, Stroke
In brief
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.
Key facts
- Study ID
- NCT07450755
- Run by
- Asklepios proresearch
- People needed
- 150
- Starts
- 2026-03-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-03-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Full record on ClinicalTrials.gov
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