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This clinical trial aims to compare the efficacy and safety of pulsed field ablation and radiofrequency ablation to treat persistent atrial fibrillation in adults.
Participants will:
Undergo pulsed field ablation or radiofrequency ablation. Keep follow-up for at least 12 months.
Traditional treatment options for persistent atrial fibrillation (PeAF) include pharmacological management, electrical cardioversion, and catheter ablation. Pulmonary vein isolation (PVI) has become the cornerstone of ablation therapy and has been shown to be effective in clinical practice. However, its efficacy is relatively limited in patients with persistent AF compared with those with paroxysmal AF, and many patients still experience recurrence after treatment.
In recent years, linear ablation strategies based on alcohol ablation have been shown to improve the one-year maintenance of sinus rhythm in patients with PeAF. Traditional radiofrequency ablation (RF) has demonstrated good outcomes but still has certain limitations when dealing with PeAF. In several clinical studies, pulsed field ablation (PFA), an emerging and innovative technique, has shown non-inferiority in treating paroxysmal AF. Furthermore, PFA has also demonstrated significant efficacy in linear ablation sites such as the mitral isthmus line, posterior left atrial wall, and tricuspid isthmus line, highlighting its potential in treating PeAF. This study aims to compare the safety and efficacy of PFA and radiofrequency ablation (RF) in the treatment of PeAF through a multi-center, prospective, randomized, open-label, non-inferiority clinical trial, to provide a safer and more effective treatment option for clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency Ablation | Active Comparator |
| |
| Pulsed Field Ablation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Field Ablation | Device | Patients will be treated with pulsed field ablation for atrial fibrillation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from any documented atrial arrhythmia lasting for >30s in the absence of antiarrhythmic therapy in 12 months after the index ablation procedure (excluding a blanking period of 3 months) | From the end of the 3-month blanking period post-ablation to the 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure | From the end of the 3-month blanking period post-ablation to the 12-month follow-up | |
| Freedom from any documented atrial fibrillation lasting for >30s in 12 months after the index ablation procedure (excluding a blanking period of 3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deyong Long | Contact | +86 135 2295 8166 | dragon2008@vip.sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Radiofrequency Ablation | Device | Patients will be treated with radiofrequency ablation for atrial fibrillation. |
|
| From the end of the 3-month blanking period post-ablation to the 12-month follow-up |
| Freedom from any documented atrial tachycardia and atrial flutter episodes in 12 months after the index ablation procedure | From the end of the 3-month blanking period post-ablation to the 12-month follow-up |
| Freedom from any documented atrial arrhythmia in the absence of antiarrhythmic therapy in 12 months after multiple ablation procedure (excluding a blanking period of 3 months) | From the end of the 3-month blanking period post-ablation to the 12-month follow-up |
| The atrial fibrillation burden (percentage of time) monitored over 12 months | From the end of the 3-month blanking period post-ablation to the 12-month follow-up |
| Cardiovascular-related hospitalizations in 12 months after the index ablation procedure | From the end of the 3-month blanking period post-ablation to the 12-month follow-up |
| Perioperative complications in 30 days after the index ablation procedure | Cardiac tamponade or perforation, permanent phrenic nerve palsy, acute coronary artery occlusion, stroke/thromboembolism/transient ischemic attack, pulmonary vein stenosis, left atrial-esophageal fistula, vascular complications requiring intervention (e.g., pseudoaneurysm, arteriovenous fistula), coronary artery spasm, renal failure due to hemolysis, death, and other treatment-related complications requiring intervention or prolonging hospitalization. | From the end of the ablation to the 30 days follow-up |
| D013568 |
| Pathological Conditions, Signs and Symptoms |