Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

Not Applicable

Active, not recruiting

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy

• Registration Number: NCT04056390
• Lead Sponsor: Cardioangiologisches Centrum Bethanien

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14
• Primary Completion: 2024-02-15
• Study Completion: 2025-02-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAA Isolation	Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy	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.
Substrate Modification	Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy	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.

Primary Outcome Measures

Name	Time	Method
Arrhythmia Recurrence	Day 91-365 after index ablation	Freedom from AF/AT

Secondary Outcome Measures

Name	Time	Method
Incidence of periprocedural complications	day 0 - day 365	Incidence of periprocedural complications such as cardiac perforation, thromboembolic events or bleeding
Number of electrical cardioversions and hospitalizations	day0 - day 365	Number of electrical cardioversions and hospitalizations

Trial Locations

Locations (7)

Universitäts Klinikum Ulm; 🇩🇪 Ulm, Germany

Universitätsklinikum Köln; 🇩🇪 Köln, Germany

Klinik für Elektrophysiologie/Rhythmologie - Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum; 🇩🇪 Bad Oeynhausen, Germany

Universitätsklinikum Schleswig Holstein; 🇩🇪 Lübeck, Germany

Universitätsmedizin Greifswald; 🇩🇪 Greifswald, Germany

Universitäres Herz- und Gefäßzentrum UKE Hamburg; 🇩🇪 Hamburg, Germany

Cardioangiologisches Centrum Bethanien; 🇩🇪 Frankfurt/Main, Germany