Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences (ASTRO AF)

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 Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Oeynhausen, Germany, 32545
    • Klinik für Elektrophysiologie/Rhythmologie - Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum
  • Frankfurt/Main, Germany, 60431
    • Cardioangiologisches Centrum Bethanien
  • Greifswald, Germany, 17475
    • Universitätsmedizin Greifswald
  • Hamburg, Germany, 20246
    • Universitäres Herz- und Gefäßzentrum UKE Hamburg
  • Köln, Germany, 50937
    • Universitatsklinikum Koln
  • Lübeck, Germany, 23538
    • Universitatsklinikum Schleswig Holstein
  • Ulm, Germany, 89081
    • Universitäts Klinikum Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Substrate Modification; 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; Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.
Active Comparator: LAA Isolation; 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; Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.

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

Collaborators and Investigators

• Sponsor: Cardioangiologisches Centrum Bethanien
• Collaborators: Medtronic; CRO Kottmann
• Investigators: Principal Investigator: Boris Schmidt, MD, Cardioangiologisches Centrum Bethanien

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Estimated): February 15, 2024
• Study Completion (Estimated): February 15, 2025

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: catheter ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: SF124/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No