Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

NCT04056390 | Unknown

• 1 other identifier: SF124/2017
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 7

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.

Conditions

Atrial Fibrillation

Keywords

catheter ablation

Outcome Measures

Primary Outcomes (1)

• Arrhythmia Recurrence

  Freedom from AF/AT

  Day 91-365 after index ablation

Secondary Outcomes (2)

• Incidence of periprocedural complications

  day 0 - day 365

• Number of electrical cardioversions and hospitalizations

  day0 - day 365

Study Arms (2)

Substrate Modification

ACTIVE COMPARATOR

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

LAA Isolation

ACTIVE COMPARATOR

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

Interventions

Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy PROCEDURE

Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.

LAA Isolation; Substrate Modification

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardioangiologisches Centrum Bethanien: lead
• Medtronic: collaborator
• CRO Kottmann: collaborator

Study Sites (7)

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

Bad Oeynhausen, 32545, Germany

Location

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, 60431, Germany

Location

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

Location

Universitäres Herz- und Gefäßzentrum UKE Hamburg

Hamburg, 20246, Germany

Location

Universitätsklinikum Schleswig Holstein

Lübeck, 23538, Germany

Location

Universitäts Klinikum Ulm

Ulm, 89081, Germany

Location

Related Publications (1)

• Schmidt B, Bordignon S, Metzner A, Sommer P, Steven D, Dahme T, Busch M, Tilz RR, Schaack D, Rillig A, Sohns C, Sultan A, Weinmann-Emhardt K, Hummel A, Vogler J, Fink T, Lueker J, Pott A, Heeger C, Chun KRJ. Ablation Strategies for Repeat Procedures in Atrial Fibrillation Recurrences Despite Durable Pulmonary Vein Isolation: The Prospective Randomized ASTRO AF Multicenter Trial. Circulation. 2024 Dec 17;150(25):2007-2018. doi: 10.1161/CIRCULATIONAHA.124.069993. Epub 2024 Oct 7.

  PMID: 39371020 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Boris Schmidt, MD

  Cardioangiologisches Centrum Bethanien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: August 1, 2019
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2025
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

DE (7)