Concomitant PFA Bsaed PVI Plus LAAC

NCT07450755 — Not applicable, Not yet recruiting, 150 participants, Asklepios proresearch

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07450755, acronym COCONUT_2
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	150 (Estimated)
Sponsor	Asklepios proresearch (Industry)
Conditions	Atrial Fibrillation (AF), Bleeding, Stroke
Interventions	Interventional LAA Closure, Pulmonary vein isolation (Procedure)
Dates	start 2026-03-01 (estimated), primary completion 2026-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-03-05, last updated 2026-03-12

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Concomitant PVI plus LAAC	Experimental	Procedure: Interventional LAA Closure; Procedure: Pulmonary vein isolation

Interventional LAA Closure (Procedure): LAA Closure to prevent stroke and bleeding
Pulmonary vein isolation (Procedure): Pulmonary vein isolation for atrial firbrillation treatment

+Outcome measures

Primary outcomes

• 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]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* Contraindications for PVI and / or LAA closure
* Pregnancy
* Previous catheter ablation for AF