Acute Cerebrovascular Accident, Atrial Fibrillation (AF), Atrial Fibrillation Recurrent, Death, Stroke
Conditions
Keywords
Radiofrequency ablation, high-power short-duration ablation, very high-power short-duration ablation, atrial fibrillation
Brief 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.
Detailed description
The study is designed to involve highly specialized centers with substantial clinical experience in the interventional treatment of atrial fibrillation (at least 300 procedures annually) and equipment enabling both conventional low-power radiofrequency ablation (35-45 W) and very high-power short-duration ablation (vHPSD) using the QMODE Plus mode (90 W) for pulmonary vein isolation performed according to the "CLOSE protocol" strategy with non-fluoroscopic navigation systems. The study population will include patients with paroxysmal and persistent forms of atrial fibrillation. This randomized open-label controlled trial will be conducted with allocation of patients into two groups according to the interventional treatment strategy applied. In the first group, pulmonary vein isolation will be performed using conventional low-power settings (35-45 W), whereas in the second group, pulmonary vein isolation will be carried out using very high-power short-duration ablation (vHPSD) with 90 W energy delivery. Patient randomization will be performed using the sealed-envelope method with a restricted block randomization scheme (block size of 10 patients, with equal allocation of 5 patients to each group). The study is expected to be completed after enrollment of 196 patients.
Interventions
PROCEDURETechnique 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.
PROCEDURETechnique 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
Bakulev Scientific Center of Cardiovascular Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
A randomized double-blind controlled trial in two groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age over 18 years old; * Atrial fibrillation resistant to antiarrhythmic therapy; * Paroxysmal form of atrial fibrillation; * Persistent form of atrial fibrillation; * The patient's consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of AF | From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 12 months | The number of patients with recurrent atrial fibrillation after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital mortality | From the date of ablation until the date of death, assessed up to 5 days | The number of patients who died in the hospital |
| Non-lethal events | From the date of ablation to the date of any of the listed events, assessed up to 5 days | 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) |
| Long-term mortality | From the date of ablation until the date of death, assessed up to 12 months | The number of patients who died during the follow-up period |
| Cerebral events | From the date of ablation until the date of the event, assessed up to 12 months | The number of patients who had a stroke or acute cerebrovascular accident or a transient ischemic attack within 12 months after ablation |
Countries
Russia
Contacts
CONTACTAndrey Filatov
PRINCIPAL_INVESTIGATORAndrey Filatov
Bakulev Scientific Center for Cardiovascular Surgery
Outcome results
None listed