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Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium

ConditionsStrokeAcute Cerebrovascular AccidentTransient Ischemic AttackDeathAtrial Fibrillation Recurrent
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBakulev Scientific Center of Cardiovascular Surgery

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Age under 18 and over 80 years old;

The presence of another cardiac pathology requiring surgical treatment;

Congenital heart defects;

Previous "open" cardiac surgery;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cryoablation

    Procedure/Surgery

    Cryoablation of the mouths of the pulmonary veins and the posterior wall of the left atrium.

  • Radiofrequency ablation

    Procedure/Surgery

    Radiofrequency ablation of pulmonary veins according to the "box isolation" type using a non-fluoroscopic navigation system.

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: CryoablationActive comparator 1 intervention
Group B: Radiofrequency ablationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cerebral events

The number of patients who had a stroke or acute cerebrovascular accident or a transient ischemic attack within 24 months after ablation.

Time frame
From the date of ablation until the date of the event, assessed up to 24 months.

Secondary outcomes

1

Hospital mortality

The number of patients who died in the hospital.

Time frame
From the date of ablation until the date of death, assessed up to 5 days.
2

Non-lethal events

Number of participants with non-lethal events. The main hospital non-lethal events (bleeding, tamponade, perforation of the walls of the heart, damage to the esophagus).

Time frame
From the date of ablation to the date of any of the listed events, assessed up to 5 days.
3

Recurrence of AF

The number of patients with recurrent atrial fibrillation after surgery.

Time frame
From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 24 months.
4

Long-term mortality

The number of patients who died during the follow-up period.

Time frame
From the date of ablation until the date of death, assessed up to 24 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bakulev Scientific Center of Cardiovascular Surgery

Lead sponsor

Source ClinicalTrials.gov
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