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

  • STATUS
    Recruiting
  • End date
    Jul 25, 2025
  • participants needed
    256
  • sponsor
    Cardioangiologisches Centrum Bethanien
Updated on 25 April 2022
ejection fraction
fibrillation
catheter ablation
pulmonary vein isolation

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.

Details
Condition Atrial Fibrillation
Treatment catheter ablation, Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy
Clinical Study IdentifierNCT04056390
SponsorCardioangiologisches Centrum Bethanien
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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