Comparative Analysis of Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium in Patients With Persistent Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Bakulev Scientific Center of Cardiovascular Surgery
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Cerebral events
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
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;
Outcomes
Primary Outcomes
Cerebral events
Time Frame: From the date of ablation until the date of the event, assessed up to 24 months.
The number of patients who had a stroke or acute cerebrovascular accident or a transient ischemic attack within 24 months after ablation.
Secondary Outcomes
- Recurrence of AF(From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 24 months.)
- Hospital mortality(From the date of ablation until the date of death, assessed up to 5 days.)
- Long-term mortality(From the date of ablation until the date of death, assessed up to 24 months.)
- Non-lethal events(From the date of ablation to the date of any of the listed events, assessed up to 5 days.)