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

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ClinicalTrials.gov Identifier: NCT04056390
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : April 11, 2022
Sponsor:
Collaborators:
Medtronic
CRO Kottmann
Information provided by (Responsible Party):
Cardioangiologisches Centrum Bethanien

Study Description
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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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Arrhythmia Recurrence [ Time Frame: Day 91-365 after index ablation ]
    Freedom from AF/AT


Secondary Outcome Measures :
  1. Incidence of periprocedural complications [ Time Frame: day 0 - day 365 ]
    Incidence of periprocedural complications such as cardiac perforation, thromboembolic events or bleeding

  2. Number of electrical cardioversions and hospitalizations [ Time Frame: day0 - day 365 ]
    Number of electrical cardioversions and hospitalizations


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056390


Contacts
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Contact: Boris Schmidt, MD 004969945028 ext 0 b.schmidt@ccb.de
Contact: Bojana Languille 004969945028 ext 144 b.languille@ccb.de

Locations
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Germany
Klinik für Elektrophysiologie/Rhythmologie - Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum Recruiting
Bad Oeynhausen, Germany, 32545
Contact: Philipp Sommer, Prof. Dr.    +49 (0) 5731-97-3380    psommer@hdz-nrw.de   
Contact: Anke Schmidt, Dipl.-Ing.    +49 (0) 5731-97-2429    anschmidt@hdz-nrw.de   
Cardioangiologisches Centrum Bethanien Recruiting
Frankfurt/Main, Germany, 60431
Contact: Boris Schmidt, Dr.    +4969945028 ext 110    b.schmidt@ccb.de   
Principal Investigator: Boris Schmidt, Dr.         
Universitätsmedizin Greifswald Recruiting
Greifswald, Germany, 17475
Contact: Mathias Busch, Dr. med.       mathias.busch@uni-greifswald.de   
Contact: Doreen Kniephoff       Doreen.Kniephoff@med.uni-greifswald.de   
Universitäres Herz- und Gefäßzentrum UKE Hamburg Recruiting
Hamburg, Germany, 20246
Contact: Andreas Metzner, PD Dr. med.    +49 (0) 40 7410 - 58320    a.metzner@uke.de   
Contact: Anke Heiermann       a.heiermann@uke.de   
Universitätsklinikum Köln Recruiting
Köln, Germany, 50937
Contact: Daniel Steven, Univ.-Prof. Dr.       daniel.steven@uk-koeln.de   
Contact: Terentieva    0221/478-88272    rhythmologie@uk-koeln.de   
Universitätsklinikum Schleswig Holstein Recruiting
Lübeck, Germany, 23538
Contact: Rolan R Tilz, MD    +49 451 500 ext 44580    Roland.Tilz@uksh.de   
Universitäts Klinikum Ulm Recruiting
Ulm, Germany, 89081
Contact: Tillman Dahme, PD Dr. med    +49 (0)731 500-45230    tillman.dahme@uniklinik-ulm.de   
Contact: Beate Polte    +49 (0)731-500-45232    beate.polte@uniklinik-ulm.de   
Sponsors and Collaborators
Cardioangiologisches Centrum Bethanien
Medtronic
CRO Kottmann
Investigators
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Principal Investigator: Boris Schmidt, MD Cardioangiologisches Centrum Bethanien
More Information
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Responsible Party: Cardioangiologisches Centrum Bethanien
ClinicalTrials.gov Identifier: NCT04056390    
Other Study ID Numbers: SF124/2017
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022

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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
Keywords provided by Cardioangiologisches Centrum Bethanien:
catheter ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Disease Attributes