Clinical trial NCT06253000: Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium
Official title: Comparative Analysis of Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium in Patients With Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Acute Cerebrovascular Accident
Transient Ischemic Attack
Death
Atrial Fibrillation Recurrent
Keywords: atrial fibrillation
radiofrequency ablation
cryoablation
left atrium
the posterior wall of the left atrium
atrial remodeling
Lead sponsor: Bakulev Scientific Center of Cardiovascular Surgery
Sponsor class: OTHER_GOV
First posted: 2024-02-12
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized double-blind controlled trial in two groups
Primary purpose: TREATMENT

Brief summary: 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: 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.

Primary outcomes:
measure: Cerebral events
timeFrame: From the date of ablation until the date of the event, assessed up to 24 months.
Secondary outcomes:
measure: Hospital mortality
timeFrame: From the date of ablation until the date of death, assessed up to 5 days.
measure: Non-lethal events
timeFrame: From the date of ablation to the date of any of the listed events, assessed up to 5 days.
measure: Recurrence of AF
timeFrame: From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 24 months.
measure: Long-term mortality
timeFrame: From the date of ablation until the date of death, assessed up to 24 months.
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Bakulev National Medical Research Center for Cardiovascular Surgery
Study officials:
affiliation: Bakulev Scientific Center for Cardiovascular Surgery
name: Andrey Filatov
role: PRINCIPAL_INVESTIGATOR
References: