COCONUT Study Concomitant PVI and LAAC

NCT06861673 | Recruiting FDA Device

• 1 other identifier: COCONUT register
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (2)

• Safety

  Peri- and postprocedural complications: Rate of: pericardial tamponade, pericardial effusion, Venouse access site haematoma

  within 3 days

• Efficacy

  Sinus rhythm after one year

  one year

Study Arms (1)

Concomitant PVI plus LAAC

Device: Pulmonary vein isolation

Interventions

Pulmonary vein isolation DEVICE

concomitant PVI and LAAC

Concomitant PVI plus LAAC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AF and PVI plus LAAC

You may qualify if:

• Indicatio for PVI and LAAC

You may not qualify if:

• Not eligible for any of the procedures PVI and LAAC

Sponsors & Collaborators

• Asklepios proresearch: lead

Study Sites (1)

Asklepios Klinik Altona

Hamburg, Hamburg, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 6, 2025
• Study Start: March 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)