Concomitant PFA Bsaed PVI Plus LAAC (COCONUT_2)

Asklepios proresearch

Status: Not yet enrolling

Conditions: Stroke; Atrial Fibrillation (AF); Bleeding

Treatments: Procedure: Interventional LAA Closure; Procedure: Pulmonary vein isolation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07450755

COCONUT_2 Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Concomitant PVI plus LAAC

Experimental group

Treatment:

Procedure: Pulmonary vein isolation

Procedure: Interventional LAA Closure