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The primary objective of this investigation is to compare the efficacy of Three different AF ablation strategies in patients with Persistent atrial fibrillation: CPVI plus Low-Voltage Areas ablation during sinus rhythm Versus. CPVI Plus Low-Voltage Areas Ablation During AF and CPVI alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STABLE-SR | Experimental |
| |
| STABLE-AF | Experimental |
| |
| CPVI alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STABLE-SR | Procedure | homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of no atrial arrhythmias greater than 30 seconds | The incidence of no atrial arrhythmias greater than 30 seconds | at least 18 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds | No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds | at least 18 months follow up |
| No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongxia Chu, doctorate | Contact | 15965165932 | chuhx1972@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2024 |
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| STABLE-AF | Procedure | homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during Atrial Fibrillation |
|
| CPVI | Procedure | ablate around the pulmonary vein orifice |
|
No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds |
| at least 18 months follow up |
| Atrial fibrillation load | Atrial fibrillation load | at least 18 months follow up |
| Procedure time | time that the patient spend in the procedure room | Surgical procedure |
| Ablation time | the total Ablation time, during CPVI and after CPVI | 1 week after patient enrollment |
| Incidence of peri-procedural complications | stroke, PV stenosis, cardiac perforation, esophageal injury and death | at least 18 months follow up |
| Jun 25, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2024 | Jun 25, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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