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NCT Number: NCT06861673

COCONUT Study Concomitant PVI and LAAC

In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and registries.8 While PVI and LAAC are both conducted in the left atrium and share the same access route, a combined concomitant approach might be beneficial for patients but is not conventionally practiced. Due to significantly shorter procedures times and high safety profile PFA based catheter ablation may be advantageous for the combined approach of PVI and LAAC. We are performing a word-wide, retrospective, multicenter registry study focusing on patients with concomitant Farapulse PFA based PVI and LAAC (WATCHMAN Flx, Boston Scientific). To evaluate safety, efficacy and efficiency in a multicenter study the COCONUT study was conducted.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Asklepios Klinik Altona

Hamburg, Free and Hanseatic City of Hamburg, Germany

Location status: Recruiting

Location contact

Christian-Hendrik Heeger, Prof. Dr.

CONTACT

[email protected]

0049401818818904

About this study

Atrial fibrillation (AF) ablation by pulmonary vein isolation and left atrial appendage closure (LAAC) are increasingly performed as individual procedures. However, there are several studies which investigated a combined concomitant approach of perfoming a cryoballoon or radiofrequency based PVI and an interventional LAAC in one procedure and safety and efficacy has been shown. 1,2,3,4 The novel ablation modality pulsed field ablation (PFA) has significantly reduced procedure duration and potentially increased safety due a specific ablation of cardiac tissue with sparing smooth muscle cells and nervous cells.6 With currently >100.000 treated patients most experience is currently available for the Farapulse PFA system (Boston Scientific). The MANIFEST-PF and MANIFEST 17K registries showed an excellent safety and efficacy profile of this novel ablation technology.6,7 In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and registries.8 While PVI and LAAC are both conducted in the left atrium and share the same access route, a combined concomitant approach might be beneficial for patients but is not conventionally practiced. Due to significantly shorter procedures times and high safety profile PFA based catheter ablation may be advantageous for the combined approach of PVI and LAAC. We are performing a word-wide, retrospective, multicenter registry study focusing on patients with concomitant Farapulse PFA based PVI and LAAC (WATCHMAN Flx, Boston Scientific). To evaluate safety, efficacy and efficiency in a multicenter study the CONOCNUT study was conducted. Two months after successful PVI and LAAC the OAC therapy could be terminated which might be beneficial for the patients especially for those with a higher bleeding risk. Further potential benefits are the reduction of periprocedural complications. Furthermore, economic factors could be beneficial due to only one concomitant procedure with one hospital stay instead of two procedures with two hospital stays.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Indicatio for PVI and LAAC

Exclusion criteria

Not eligible for any of the procedures PVI and LAAC

Treatment and study plan

Pulmonary vein isolation

Device

concomitant PVI and LAAC

Primary outcomes

  1. Safety

    Time frame: within 3 days

    Peri- and postprocedural complications:

    Rate of: pericardial tamponade, pericardial effusion, Venouse access site haematoma

  2. Efficacy

    Time frame: one year

    Sinus rhythm after one year

Sponsors and collaborators

Lead sponsor

Asklepios proresearch

Industry

Registry information

Official study title

COnCOmitaNt Pulse Field Ablation Based pUlmonary Vein Isolation and lefT Atrial Appendage Closure - The COCONUT Study

Acronym: COCONUT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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