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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation | Active Comparator | Cryoablation of the mouths of the pulmonary veins and the posterior wall of the left atrium. |
|
| Radiofrequency ablation | Active Comparator | Radiofrequency ablation of pulmonary veins according to the "box isolation" type using a non-fluoroscopic navigation system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Procedure | Cryoablation of the mouths of the pulmonary veins and the posterior wall of the left atrium. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral events | The number of patients who had a stroke or acute cerebrovascular accident or a transient ischemic attack within 24 months after ablation. | From the date of ablation until the date of the event, assessed up to 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital mortality | The number of patients who died in the hospital. | From the date of ablation until the date of death, assessed up to 5 days. |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrey Filatov | Contact | +7(495) 414-77-02 | agfilatov@bakulev.ru |
| Name | Affiliation | Role |
|---|---|---|
| Andrey Filatov | Bakulev Scientific Center for Cardiovascular Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakulev National Medical Research Center for Cardiovascular Surgery | Recruiting | Moscow | 121552 | Russia |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| D003643 | Death |
| D001281 | Atrial Fibrillation |
| D064752 | Atrial Remodeling |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
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A randomized double-blind controlled trial in two groups
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| Radiofrequency ablation | Procedure | Radiofrequency ablation of pulmonary veins according to the "box isolation" type using a non-fluoroscopic navigation system. |
|
| From the date of ablation to the date of any of the listed events, assessed up to 5 days. |
| Recurrence of AF | The number of patients with recurrent atrial fibrillation after surgery. | From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 24 months. |
| Long-term mortality | The number of patients who died during the follow-up period. | From the date of ablation until the date of death, assessed up to 24 months. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D020763 | Pathological Conditions, Anatomical |