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The purpose of this study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application.
The trial will be conducted at a clinical center with appropriate clinical cases, and paroxysmal atrial fibrillation ablation procedures will be performed by an authorized investigator using the trial product. The effectiveness and safety of the cardiac pulse ablation system in the treatment of paroxysmal atrial fibrillation will be verified by collecting the treatment success rate, immediate ablation success rate, procedure time and device use evaluation within 12 months after the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group target value method | Experimental | This trial is a prospective, multicenter, single-group target value method study. All subjects are treated uniformly with the pulse ablation system provided in this protocol for paroxysmal AF, and the test results for the main indicators are statistically compared with the target values, a widely accepted standard in professional medicine, and the test results are considered to be attained if the one-sided 95% confidence interval for the test results is not lower than the target values. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation Catheter | Device | Routinely placing a coronary sinus electrode catheter, puncturing the interatrial septum, placing one sheath into the left atrium, confirming that the catheter is well in place, and setting the treatment time of the pulse ablation system in advance. Pulmonary vein-by-pulmonary vein ablation using a circular pulse catheter, waiting for the end of the pulse ablation phase and immediate effect confirmation. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Treatment Success at 3-Month Post-Procedure | Refers to the postoperative phase (blank) after 3 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number. | Refers to the postoperative phase (blank) after 3 months postoperatively |
| Rate of Treatment Success at 6-Month Post-Procedure | Refers to the postoperative phase (blank) after 6 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number. | Refers to the postoperative phase (blank) after 6 months postoperatively |
| Rate of Treatment Success at 12-Month Post-Procedure | Refers to the postoperative phase (blank) after 12 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number. | Refers to the postoperative phase (blank) after 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate success rate: pulmonary vein isolation after ablation | Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled. Validation was a 20-minute wait after successful electrical isolation of the pulmonary vein, followed by reconfirmation of pulmonary vein block | 1 Day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of early onset (within 7 days of ablation) adverse events | The primary safety endpoint | Within 7 days after the surgery |
| Incidence of adverse events and serious adverse events associated with the study device |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Northern Theater Command, No. 83 Wenhua Road, Shenhe District, Shenyang, Liaoning Province | Shenyang | Liaoning | 110016 | 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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This trial is a prospective, multicenter, single-group target value method study
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Non-blind method
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| Evaluation of Pulse Ablation Catheter | Evaluation of catheter operation performance;Catheter ablation parameters | 1 Day of surgery |
| Evaluation of Pulse Ablation equipment | System software operability;System operation stability;Hardware connection validity | 1 Day of surgery |
Secondary Security Endpoints
| Within 12 months after sign the informed consent form |
| D013568 |
| Pathological Conditions, Signs and Symptoms |