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The electrophysiological mechanisms of atrial fibrillation remain disagreements. The goal of this clinical trail is to propose a new electrophysiological mechanism hypothesis of atrial fibrillation(AF),meanwhile, the investigators sought to test the hypothesis that the superposition electrograms (SPEs) recorded during atrial fibrillation could be used as target sites for catheter ablation of atrial fibrillation.
Catheter ablation for atrial fibrillation is a promising therapy, whose success is limited in part by uncertainty in the electrophysiological mechanisms of AF. The investigators recruited 100 subjects including paroxysmal(40%) and persistent (60%) AF. Cases were prospectively treated, in a 2-arm 1:1 design, by ablation SPEs followed by pulmonary vein isolation(PVI) ablation (n=50), or pulmonary vein isolation alone (n =50).
All procedures are guided by CARTO (Biosense Webster) electroanatomic mapping system and ablation is performed using open irrigated catheters with contact force (CF) sensing (Thermocool SmartTouch, Biosense Webster). Study Group underwent electroanatomic mapping during AF. Using CARTO to identify areas associated with SPEs. Radiofrequency ablation of the area with SPEs was performed, aiming to eliminate SPEs and convert to sinus rhythm or atrial tachycardia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With additional SPEs ablation | Experimental | Patients who undergo PVI + SPEs ablation using ThermoCool SmartTouch catheter. |
|
| Control Group | Active Comparator | Patients who undergo PVI alone using ThermoCool SmartTouch catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVI + SPEs ablation | Procedure | electrophysiology substrate mapping is the critical difference between both groups. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from AF during follow-up | At the one-year follow-up,AF occurring in the first 3 months after the ablation (blanking period) were censored.Beyond this, any AF episode that lasted for more than 30 seconds was categorized as a recurrence. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Acute success rate of AF termination during ablation procedure | Conversion of AF to normal sinus rhythm or atrial tachyarrhythmias during ablation procedure. | one year |
| Complications | Serious adverse events included death, pericardial tamponade , cerebrovascular events, significant PV stenosis , left atrial-esophageal fistula. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mingli Zhou, M.D. | The Second Affiliated Hospital of Kunming Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9725923 | Result | Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003. | |
| 15172410 | Result | Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054. |
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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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| PVI ablation | Procedure | electrophysiology substrate mapping is the critical difference between both groups. |
|
| one year |
| freedom from documented AF/AT episode | freedom from any documented AF/AT episode lasting > 30 s after the blanking period without anti-arrhythmic drugs during the 12-month follow-up after a single procedure. | one year |
| 22818076 | Result | Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |