Concomitant PFA Bsaed PVI Plus LAAC

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07450755

Acronym

COCONUT_2

Enrollment

150

Registered

2026-03-05

Start date

2026-03-01

Completion date

2027-12-31

Last updated

2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF), Bleeding, Stroke

Keywords

Catheter ablation, Pulsed field ablation, LAAClosure

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.

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.

Interventions

PROCEDUREInterventional LAA Closure

LAA Closure to prevent stroke and bleeding

PROCEDUREPulmonary vein isolation

Pulmonary vein isolation for atrial firbrillation treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Retrospective study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
• 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

Contacts

CONTACTChristian-Hendrik Heeger, MD

c.heeger@asklepios.com0049-40-181881-8904

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026