COCONUTPulse Field Ablation and Left Atrial Appendage Closure for Atrial Fibrillation
Data Collection
Arrhythmias, Cardiac+3
+ Atrial Fibrillation
+ Cardiovascular Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.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