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This study investigates two treatments for atrial fibrillation (AF) patients without low-voltage-areas (LVAs). It aims to determine whether adding transition zone modification (TZM) to the pulmonary vein isolation (PVI) improves long-term outcomes compared to PVI alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: PVI-alone arm | Active Comparator |
| |
| Experimental: PVI+TZM arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary vein isolation plus transition zone modification | Procedure | For those who are randomized to PVI+TZM arm, additional TZM should be performed after finishing PVI ablation. PVI could be performed using open-irrigated contact-force catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From AF and/or ATs With or Without Antiarrhythmic Drugs (AADs) | Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each episode lasts > 30 seconds. | at least 12 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Peri-procedural Complications | Incidence of Peri-procedural Complications：stroke, cardiac perforation, PV stenosis, esophageal injury and death | 1 week after patient enrollment |
| Total procedure time |
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Inclusion Criteria:
Aged 18 to 80 years AF referring for ablation No prior history of AF Absence of low-voltage areas during substrate mapping Presence of transition zone during substrate mapping Sign informed consent
Exclusion Criteria:
Presence of left atrial thrombus Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease Untreated hypothyroidism or hyperthyroidism Dialysis-dependent terminal renal failure Life expectancy <12 months due to non-cardiovascular causes. Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study Female under pregnancy or breast-feeding Involved in other studies
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue Qiu, M.D. | Contact | +86-13057657758 | qiuyue@njmu.edu.cn | |
| Hongwu Chen, M.D. | Contact | +86-15996291298 | chenhongwu@njmu.edu.cn |
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Follow-up physicians are blinded to treatment allocation
| Pulmonary vein isolation alone | Procedure | In periprocedural period, all antiarrhythmic drugs were discontinued for at least 5 half-lives and amiodarone for 2 months before the procedure. An electrophysiological study was performed after overnight fasting and mild sedated state with administration of intravenous midazolam and fentanyl. PVI should be performed under the CARTO or Ensite electroanatomic mapping system using an open-irrigated contact-force ablation catheter. |
|
time that the patient spend in the procedure room
| 1 week after patient enrollment |
| Total fluoroscopic time | the total fluoroscopy time, during PVI alone or PVI plus low-voltage substrate modification | 1 week after patient enrollment |
| Total RF delivery time | The cumulative duration (in minutes) of active radiofrequency (RF) energy application to the atrial tissue during the ablation procedure. | 1 week after patient enrollment |
| 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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