Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium

Last updated: February 2, 2024
Sponsor: Bakulev Scientific Center of Cardiovascular Surgery
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cardiac Disease

Atrial Fibrillation

Treatment

Cryoablation

Radiofrequency ablation

Clinical Study ID

NCT06253000
#4.10.11.2022
  • Ages 18-80
  • All Genders

Study Summary

Atrial fibrillation (AF) is the cause of 20% of strokes, and the risk of stroke in a person suffering from this arrhythmia increases by 5 times. Ischemic stroke in patients with AF is often fatal and, compared with stroke of other etiology, leads to the most pronounced disability and more often recurs. Accordingly, the risk of death in patients with AF-related stroke is 2 times higher, and treatment costs increase 1.5 times.

The main interventional method of treating AF, available in most medical institutions, is the use of radio frequency and/or cryoenergy to eliminate destructive damage to the left atrium (LA).

The aim of this study is to compare two different interventional methods and identify predictors of recurrence in patients with persistent and long-term AF.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age over 18 years old;
  • Atrial fibrillation resistant to antiarrhythmic therapy;
  • Persistent and long-persisting form of atrial fibrillation;
  • The patient's consent to participate in the study.

Exclusion

Exclusion Criteria:

  • Age under 18 and over 80 years old;
  • The presence of another cardiac pathology requiring surgical treatment;
  • Congenital heart defects;
  • Previous "open" cardiac surgery;
  • Bone marrow diseases;
  • Pathology of the blood coagulation system;
  • The left ventricular ejection fraction is less than 40%;
  • Moderate to severe renal insufficiency (creatinine clearance <50 ml/min);
  • Drug-resistant hypertension (despite hypotensive therapy);
  • Organically altered mitral valve;
  • There are reasons to assume that the patient will not show up for subsequent visits (control points of the study) for various reasons;
  • The patient's participation in another clinical trial.

Study Design

Total Participants: 158
Treatment Group(s): 2
Primary Treatment: Cryoablation
Phase:
Study Start date:
June 10, 2023
Estimated Completion Date:
December 30, 2026

Connect with a study center

  • Bakulev National Medical Research Center for Cardiovascular Surgery

    Moscow, 121552
    Russian Federation

    Active - Recruiting

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