COCONUT Study Concomitant PVI and LAAC

NCT ID: NCT06861673

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-12-01

Brief Summary

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.

Detailed Description

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.

Conditions

Atrial Fibrillation (AF)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Concomitant PVI plus LAAC

Pulmonary vein isolation

Intervention Type: DEVICE

concomitant PVI and LAAC

Interventions

Pulmonary vein isolation

concomitant PVI and LAAC

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Indicatio for PVI and LAAC

Exclusion Criteria

Not eligible for any of the procedures PVI and LAAC

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asklepios proresearch

INDUSTRY

Sponsor Role: lead

Responsible Party

Prof. Christian-Hendrik Heeger

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asklepios Klinik Altona

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Christian-Hendrik Heeger, Prof. Dr.

Role: primary

c.heeger@asklepios.com

0049401818818904

Other Identifiers

COCONUT register

Identifier Type: -

Identifier Source: org_study_id