Individualised Mapping in Persistent AF Ablation

Study Overview
=================
Brief Summary
-----------------
A clinical randomised trial to compare strategies for ablation in persistent and long-standing persistent atrial fibrillation comprising of two arms: pulmonary veins isolation (PVI) only and PVI + individualised mapping-guided ablation (Cartofinder, Biosense Webster Inc.)

Official Title
-----------------
Individualised MApping-Guided Ablation to Improve Outcomes in pErsistent Atrial Fibrillation

Conditions
-----------------
Persistent Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Pulmonary veins isolation + Cartofinder-guided ablation
* Procedure: Pulmonary veins isolation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Signed informed consent. Scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation. In atrial fibrillation at the time of the index procedure. Exclusion Criteria: Paroxysmal atrial fibrillation. Previous ablation procedure for atrial fibrillation. Left ventricular ejection fraction < 45% Obesity with BMI > 35 kg/m2 Congenital heart disease. Previous cardiac surgery with atriotomy. Previous left atrial appendage closure/ligation. Contraindications to systemic anticoagulation, catheter ablation, and/or general anaesthesia. Pregnancy Current enrolment in a study evaluating another device or drug.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVI only<br>Patients in this arm will undergo only standard pulmonary veins isolation with radiofrequency (RF) energy to treat their AF. | Procedure: Pulmonary veins isolation<br>* Wide area circumferential pulmonary veins isolation<br>|
| Experimental: PVI + IM<br>Patients in this arm will undergo standard wide area circumferential pulmonary veins isolation along with radiofrequency energy and additional RF ablation guided by individualised mapping with Cartofinder to treat their AF. | Procedure: Pulmonary veins isolation + Cartofinder-guided ablation<br>* The individualised mapping with Cartofinder intends to identify areas with the repetitive atrial activation patterns which are targeted with focal or linear ablation anchored on at least one end in an anatomical or electrical barrier.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial arrhythmia | Freedom from any atrial arrhythmia without the use of antiarrhythmic drugs | 12 monts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial fibrillation | Freedom from atrial fibrillation without the use of antiarrhythmic drugs | 12 months | 
| Atrial fibrillation burden reduction | Reduction of the atrial fibrillation burden by 75% compared to baseline | 12 months | 
| Absolute atrial fibrillation burden | Absolute atrial fibrillation burden after a single, first-time ablative procedure guided by individualised mapping vs. standard approach. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
persistent atrial fibrillation, catheter ablation, individualized mapping, focal activity, rotational activity