Recruiting

COCONUTPulse Field Ablation and Left Atrial Appendage Closure for Atrial Fibrillation

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What is being collected

Data Collection

Who is being recruted

Arrhythmias, Cardiac+3

+ Atrial Fibrillation

+ Cardiovascular Diseases

+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2025
See protocol details

Summary

Principal SponsorAsklepios proresearch
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2025

Actual date on which the first participant was enrolled.

The COCONUT study focuses on a combined approach to treat atrial fibrillation (AF), a common heart rhythm disorder. This approach involves two procedures: pulmonary vein isolation (PVI) using a novel ablation method called pulsed field ablation (PFA), and left atrial appendage closure (LAAC). These procedures are typically performed separately, but the study aims to investigate the benefits of performing them together. The study targets patients with non-valvular AF who are at high risk for stroke and cannot take long-term oral anticoagulation. The potential benefits include shorter procedure times, increased safety, and improved patient outcomes. In this worldwide, retrospective, multicenter registry study, participants undergo both PVI using the Farapulse PFA system and LAAC with the WATCHMAN Flx device. The study evaluates the safety, efficacy, and efficiency of this combined approach. The primary outcomes measured include the maintenance of a normal heart rhythm (sinus rhythm) one year after the procedure, and the rate of complications during and after the procedure, such as pericardial tamponade, pericardial effusion, and venous access site hematoma. The study also explores potential benefits such as reducing the need for oral anticoagulation therapy and decreasing periprocedural complications, as well as economic benefits from a single hospital stay instead of two.

Official TitleCOnCOmitaNt Pulse Field Ablation Based pUlmonary Vein Isolation and lefT Atrial Appendage Closure - The COCONUT Study
NCT06861673
Principal SponsorAsklepios proresearch
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

1 inclusion criteria required to participate
Indicatio for PVI and LAAC

1 exclusion criteria prevent from participating
Not eligible for any of the procedures PVI and LAAC

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Asklepios Klinik Altona

Hamburg, GermanyOpen Asklepios Klinik Altona in Google Maps
Recruiting
One Study Center