Prospective randomized controlled trial “Comparative analysis of radiofrequency and cryoablation of the posterior wall of the left atrium in patients with persistent atrial fibrillation” in the Russian Federation (“PRIORITY-AF”): rationale, objectives and design

Authors: Golukhova E.Z., Filatov A.G., Avanesyan G.A., Shvartz V.A., Shalov R.Z., Temirbulatov I.A., Sapelnikov O.V., Rzaev F.G.

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Type:  Original articles


DOI: https://doi.org/10.24022/1997-3187-2024-18-3-317-327

Received / Accepted:  02.08.2024 / 27.08.2024



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Abstract

Objective. To compare two different interventional treatment methods and to identify predictors of recurrence in patients with persistent and long-term persistent AF.

Material and methods. “PRIORITY-AF” is an all-Russian prospective multicenter registered study of patients with persistent and long-term persistent AF in the Russian Federation. Clinics with experience and equipment in treating such patients were invited to participate in the study. The study is associated with the study of the effectiveness of two different techniques: cryoballoon isolation of the pulmonary vein orifices (CBA) and the posterior wall of the left atrium and radiofrequency isolation (RFA) of the pulmonary veins by box isolation using a non-fluoroscopic navigation system. Evaluation of the effectiveness of CBA and RFA will be carried out in the long-term period for 12 months. In 2024, it is planned to perform RFA and/or CBA in 79 patients with an assessment of the effectiveness parameters after 6 and 12 months. In 2025, it is planned to perform RFA and/or CBA in 79 patients with an assessment of the efficacy parameters after 6 and 12 months. Thus, a sample of 158 patients (79 patients per group) will be sufficient to detect differences in the efficacy of the methods with 90% power at a 5% significance level. In 2024 and 2025, it is planned to recruit 158 patients for RFA and/or CBA, and in 2026 – prospective observation.

Results. The study is registered on the international clinical trials website ClinicalTrials.gov, registration number NCT0625300. Three research centers located in Moscow are participating in it: A.N. Bakoulev National Medical Research Center of Cardiology, academician E.I. Chazov National Medical Research Center of Cardiology and I.V. Davydovskiy City Clinical Hospital. The first patient was enrolled in the study on December 1, 2023. Patient recruitment continues according to the study enrollment schedule.

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About Authors

  • Elena Z. Golukhova, Dr. Med. Sci., Professor, Academician of RAS, Director; ORCID
  • Andrey G. Filatov, Dr. Med. Sci., Head of Department; ORCID
  • Grayr A. Avanesyan, Cand. Med. Sci., Researcher, Cardiovascular Surgeon; ORCID
  • Vladimir A. Shvartz, Dr. Med. Sci., Leading Researcher; ORCID
  • Ruslan Z. Shalov, Cand. Med. Sci., Junior Researcher, Cardiovascular Surgeon; ORCID
  • Ibragim A. Temirbulatov, Cardiovascular Surgeon; ORCID
  • Oleg V. Sapelnikov, Dr. Med. Sci., Chief Researcher, Head of Laboratory; ORCID
  • Farkhad G. Rzaev, Cand. Med. Sci., Head of Department; ORCID

Chief Editor

Leo A. Bockeria, MD, PhD, DSc, Professor, Academician of Russian Academy of Sciences, President of Bakoulev National Medical Research Center for Cardiovascular Surgery