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Recruiting NCT06253000

Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium

No phase Interventional Stroke Acute Cerebrovascular Accident Transient Ischemic Attack Death

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cryoablation, Radiofrequency ablation.
Who it may be relevant to
Registry conditions: Stroke, Acute Cerebrovascular Accident, Transient Ischemic Attack, Death. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparative Analysis of Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium in Patients With Persistent Atrial Fibrillation

Overview

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.

Interventions

  • Procedure Cryoablation
    Cryoablation of the mouths of the pulmonary veins and the posterior wall of the left atrium.
  • Procedure Radiofrequency ablation
    Radiofrequency ablation of pulmonary veins according to the "box isolation" type using a non-fluoroscopic navigation system.

Primary outcome measures

  • Cerebral events [Time frame: From the date of ablation until the date of the event, assessed up to 24 months.]
Secondary outcome measures (4)
  • Hospital mortality [Time frame: From the date of ablation until the date of death, assessed up to 5 days.]
  • Non-lethal events [Time frame: From the date of ablation to the date of any of the listed events, assessed up to 5 days.]
  • Recurrence of AF [Time frame: From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 24 months.]
  • Long-term mortality [Time frame: From the date of ablation until the date of death, assessed up to 24 months.]

Eligibility criteria

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Russia · 1 center
  • Bakulev National Medical Research Center for Cardiovascular Surgery — Moscow

Identifiers

NCT: NCT06253000 · #4.10.11.2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗