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Comparative Evaluation of the Efficacy and Safety of High-Power Short-Duration Radiofrequency Ablation and Standard Low-Power Ablation in Catheter Treatment of Atrial Fibrillation

ConditionsAtrial Fibrillation (AF)StrokeAcute Cerebrovascular AccidentAtrial Fibrillation RecurrentDeath
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBakulev Scientific Center of Cardiovascular Surgery

About this trial

Atrial fibrillation (AF) is the most common cardiac arrhythmia and represents one of the leading causes of cardiovascular morbidity and mortality. According to current data, AF is associated with approximately 20% of all ischemic strokes, while the risk of stroke in patients with this arrhythmia is increased fivefold. Ischemic stroke in patients with AF is characterized by a more severe clinical course, more frequently results in death, is associated with significant disability, and carries a higher risk of recurrence compared with strokes of other etiologies. Consequently, the risk of death in patients with AF-associated stroke is doubled, while the economic costs of treatment increase by an average of 1.5 times.

The aim of the present study is to perform a comparative evaluation of the efficacy of two interventional treatment strategies for atrial fibrillation: very high-power short-duration radiofrequency ablation (90 W) and conventional low-power radiofrequency ablation (35-45 W) for pulmonary vein isolation using the "CLOSE protocol" approach with a non-fluoroscopic navigation system. The efficacy of the interventions will be assessed both in the early postoperative period and during long-term follow-up over 12 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age over 18 years old;

Atrial fibrillation resistant to antiarrhythmic therapy;

Paroxysmal form of atrial fibrillation;

Persistent form of atrial fibrillation;

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

  • Technique of radiofrequency ablation using very high-power short-duration ablation parameters

    Procedure/Surgery

    Radiofrequency ablation is performed in QMODE Plus mode (90 W, 4 s per application) with esophageal temperature monitoring (not exceeding 38.5 °C), using a steerable introducer and a contact force of 5-15 g.

  • Technique of radiofrequency ablation using low-power settings

    Procedure/Surgery

    Radiofrequency ablation is performed at a power of 35 W and an application duration of 10-15 s with monitoring of the ablation index (400-550 depending on the anatomical zone), esophageal temperature (not exceeding 38.5 °C), and a contact force of 5-15 g.

Treatment groups

196 Participants
are divided into 2 treatment groups
Group A: Technique of radiofrequency ablation using very high-power short-duration ablation parametersActive comparator 1 intervention
Group B: Technique of radiofrequency ablation using low-power settingsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 12 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

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 12 months
4

Cerebral events

The number of patients who had a stroke or acute cerebrovascular accident or a transient ischemic attack within 12 months after ablation

Time frame
From the date of ablation until the date of the event, assessed up to 12 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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