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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

NCT07728539 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-07-27

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Fibrillation (AF)
  • Stroke
  • Acute Cerebrovascular Accident
  • Atrial Fibrillation Recurrent
  • Death

Interventions

PROCEDURE

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

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.

PROCEDURE

Technique of radiofrequency ablation using low-power settings

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.

Sponsors & Collaborators

  • Bakulev Scientific Center of Cardiovascular Surgery

    lead OTHER_GOV

Principal Investigators

  • Andrey Filatov · Bakulev Scientific Center for Cardiovascular Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-06-01
Completion
2029-06-01

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07728539 on ClinicalTrials.gov