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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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This study is a prospective, single-center, single-arm clinical trial planning to screen and enroll 200 subjects. It aims to evaluate the efficacy and safety of pulsed field ablation (PFA) using the FARAPULSEâ„¢ system for pulmonary vein isolation (PVI) and superior vena cava isolation (SVCI) in Chinese patients with paroxysmal atrial fibrillation (PAF). Baseline preoperative data, along with intraoperative and postoperative follow-up information, will be collected. The primary endpoint is the proportion of subjects achieving successful PVI and SVCI using solely the FARAPULSEâ„¢ PFA system. Secondary endpoints include long-term procedural success rates and various procedural parameters. Additionally, the incidence of adverse events will be recorded as safety endpoints. The study adopts a single-arm target value design hypothesis, and research data will also be compared with historical data from patients treated with radiofrequency ablation for PVI and SVCI to further evaluate the efficacy of PFA. Subgroup analysis will be conducted in patients with heart failure to assess the efficacy and safety of PFA in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Field Ablation | Experimental | Using the FARAPULSEâ„¢ System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Field Ablation | Device | Pulsed Field Ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| PVI and SVCI | The proportion of subjects achieving successful PVI and SVCI using solely the FARAPULSEâ„¢ PFA system | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term procedural success rates | The percentage of subjects, among the total enrolled, who remained free of recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia, with any episode lasting >10 seconds on standard ECG or >30 seconds on Holter monitoring. | From the end of the 3-month blanking period post-ablation to the 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Total procedure time | The duration from femoral venous puncture until the removal of all devices from the body | Periprocedural |
| Anesthesia induction time | The duration from the administration of anesthetic agents until achieving a satisfactory anesthetic state (allowing initiation of the procedure) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunfeng Dai, M.D. | Contact | 86-021-64041990 | dai.chunfeng@zs-hospital.sh.cn |
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| Perioperative complications | Serious bradyarrhythmia requiring permanent pacemaker implantation, cardiac tamponade/cardiac perforation, thromboembolic events, severe coronary artery spasm (>90% stenosis), phrenic nerve palsy, acute hemolysis and hemolysis-induced renal failure, vascular access complications requiring surgical or interventional management, atrioesophageal fistula, pulmonary vein stenosis, and death. | From the end of the ablation to the 12-month follow-up |
| Periprocedural |
| Left atrial operation time | The duration from the entry of the ablation catheter into the left atrium until its withdrawal from the left atrium | Periprocedural |
| Right atrial operation time | The duration from the withdrawal of the ablation catheter from the left atrium until its complete removal from the body | Periprocedural |
| Number of ablations | Total number of ablations, number of ablations for pulmonary vein isolation, and number of ablations for superior vena cava isolation. | Periprocedural |
| 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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