Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

Cardioangiologisches Centrum Bethanien256 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

256

Conditions

Atrial Fibrillation

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (7)

Klinik für Elektrophysiologie/Rhythmologie - Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum

Bad Oeynhausen, Germany

Universitätsklinikum Köln

Cologne, Germany

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, Germany

Universitätsmedizin Greifswald

Greifswald, Germany

Universitäres Herz- und Gefäßzentrum UKE Hamburg

Hamburg, Germany

Universitätsklinikum Schleswig Holstein

Lübeck, Germany

Universitäts Klinikum Ulm

Ulm, Germany

Outcomes

Primary Outcomes

Arrhythmia Recurrence

Freedom from AF/AT

Time frame: Day 91-365 after index ablation

Secondary Outcomes

Incidence of periprocedural complications

Incidence of periprocedural complications such as cardiac perforation, thromboembolic events or bleeding

Time frame: day 0 - day 365

Number of electrical cardioversions and hospitalizations

Time frame: day0 - day 365