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This is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focal pulse ablation system | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focal Pulse field Ablation | Device | Bidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute procedural success | Acute procedural success is defined as the creation of bidirectional conduction block across the cavo-tricuspid isthmus immediately and 30 minutes after ablation. | immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic success | Chronic success is defined as the absence of recurrent atrial flutter at 6 months post-ablation according to electrocardiogram data, including electrocardiogram, 24-hour Holter. | 6 months after procedure |
| Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haitao Yang | Contact | +8637158680341 | dinova_ep@dnaeps.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 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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Total procedure time (defined as the total time from initial femoral venipuncture to final catheter removal), catheter dwell time (time between the pulsed field ablation catheter entering the left atrium and its withdrawal from the left atrium), pulse discharge time (The total time of delivering pulse energy through the pulsed field ablation catheter, single ablation time ablation times), total X-ray exposure time (the total time of X-ray imaging of the catheter) |
| immediately after the procedure |
| Incidence of device-related major adverse events (MAE) within 7 days after ablation | Device-related MAE includes death, myocardial infarction, pulmonary embolism, stroke /TIA, severe pericardial effusion, and complete atrioventricular block. | within 7 days after ablation |
| Incidence of device-related severe adverse events (SAE) | Device-related SAE refers to a device-related event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function. | 3 months and 6 months after procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |