Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate different ablation strategies in patients with AF recurrences despite chronic PVI after prior catheter ablation. The present study is a multi-centre prospective randomized study enrolling 256 patients with drug-refractory AF despite previous AF ablation. After PV remapping confirming durable PVI patients will be assigned to 2 different groups: Group A: Substrate modification. After obtaining a voltage map of the LA, substrate modification will be performed aiming at low-voltage areas (LVA) < 0.5mV. Group B: LAA isolation. Patients will undergo LAA-isolation using the cryoballoon (CB). Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (CARTO, EnSite) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance). The primary endpoint is freedom from documented recurrence of AF or any atrial tachyarrhythmia lasting > 30 seconds between day 91 and 365 after the index procedure.

Official Title
-----------------
Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

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

Intervention / Treatment
-----------------
* Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Symptomatic non-valvular atrial fibrillation despite prior ablation with an indication for re-ablation according to current guidelines. Permanent pulmonary vein isolation according to mapping with a spiral mapping catheter Age 18-85 years. Left atrial size < 55mm. Left ventricular ejection fraction ≥ 45%. Patient is able to provide informed consent and is willing to comply with the study protocol. Exclusion Criteria: Contraindications for repeat ablation Reconnected pulmonary veins according to mapping results with a spiral mapping catheter Minimal diameter of LAA neck ≥25mm History of mitral valve surgery Severe mitral valve regurgitation Inability to be treated with oral anticoagulation Presence of intracardiac thrombi Chronic obstructive pulmonary disease treated with long acting bronchodilatators Asthma Obstructive sleep apnea syndrome Pregnancy Participation in other clinical studies Unwilling to follow the study protocol and to attend follow-up visits

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Substrate Modification<br>After obtaining a voltage map of the LA, substrate modification by catheter ablation using an irrigated radio frequency current ablation catheter will be performed aiming at low-voltage areas (LVA) < 0.5mV. | Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy<br>* Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.<br>|
| Active Comparator: LAA Isolation<br>Patients will undergo LAA-isolation using the cryoballoon (CB). Six weeks later patients will undergo re-mapping. In case of residual conduction LAA-reisolation will be performed. In case of durable LAA isolation, interventional LAA occlusion is recommended. | Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy<br>* Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmia Recurrence | Freedom from AF/AT | Day 91-365 after index ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of periprocedural complications | Incidence of periprocedural complications such as cardiac perforation, thromboembolic events or bleeding | day 0 - day 365 | 
| Number of electrical cardioversions and hospitalizations | Number of electrical cardioversions and hospitalizations | day0 - day 365 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
catheter ablation