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| Name | Class |
|---|---|
| The Shanghai Yangpu Central Hospital | UNKNOWN |
| Jinshan Hospital Affiliated to Fudan University | UNKNOWN |
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The design of this study is an intervention, randomized, controlled study and contains two randomized groups:(1)AF-termination group;(2)Prespecified-ablation group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AF-termination group | Experimental |
| |
| Prespecified-ablation group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrial Fibrillation Termination | Procedure | Pursuing Atrial Fibrillation Termination as a Procedural Endpoint |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months follow up after a single ablat | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 monthsï¼› | 12 months | |
| Freedom from AF/AT/AFL after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | 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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| Prespecified Ablation | Procedure | Prespecified Ablation Strategy Followed by Cardioversion |
|
| 12 months |
| Freedom from AF after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months | 12 months |
| Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure | 12 months |
| Incidence of periprocedural adverse events. | 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |