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| Name | Class |
|---|---|
| Shanghai MicroPort EP MedTech Co., Ltd. | INDUSTRY |
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The goal of this retrospective study is to compare the long-term follow-up outcomes of pulses field ablation (PFA) Vs. radiofrequency ablation (RFA) for the patients with paroxysmal supraventricular tachycardia (PSVT). The main question to answer is:
Does the PFA was more effecient and safer that RFA for treatment of PSVT during procedure and after 1-year follow-up? Researchers will compare the acute and long-term efficiency and safety between PFA and RFA.
The goal of this retrospective study is to compare the long-term follow-up outcomes of PFA Vs. RFA for the patients with PSVT. The main question to answer is:
Does the PFA was more effecient and safer that RFA for treatment of PSVT during procedure and after 1-year follow-up? Researchers will compare the acute and long-term efficiency and safety between PFA and RFA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFA group | A retrospective analysis was conducted on 214 patients with PSVT recieving PFA who met the inclusion and exclusion criteria and visited at the First Affiliated Hospital of Ningbo University, the Third People's Hospital of Chengdu, the Xiamen Cardiovascular Hospital of Xiamen University, the First Hospital of Jilin University, the Seventh People's Hospital of Zhengzhou, Shanghai General Hospital, and Jiangxi Provincial People's Hospital from October 2022 to June 2024. These patients were included in the PFA group. Basic clinical information, procedural data, and the efficiency and safety post 1-year follow-up were collected and analyzed. |
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| RFA group | A retrospective analysis for control group was conducted on patients with PSVT reciecing RFA who met the inclusion and exclusion criteria and visited at the First Affiliated Hospital of Ningbo University the Third People's Hospital of Chengdu, the Xiamen Cardiovascular Hospital of Xiamen University, the First Hospital of Jilin University, the Seventh People's Hospital of Zhengzhou, Shanghai General Hospital, and Jiangxi Provincial People's Hospital from October 2022 to June 2024. 214 patients approached by RFA were matched 1:1 by propensity score to a similar population treated by PFA. Basic clinical information, procedural data, as well as the efficiency and safety of 1-year follow-up were collected and analyzed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focal Pulsed Field Ablation (PFA) | Procedure | Patients in the PFA group underwent ablation procedures utilizing a force-sensing PFA catheter for the treatment of PSVT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute and long-term follow-up success rate | The Primary endpoints for efficacy included the number of subjects with acute and long-term follow-up success post ablation. The acute success was confirmed by noninducibility of clinical PSVT after programmed stimuli and drug administration after15 minutes waiting time. The long-term follow-up success was defined as the absence of clinical PSVT during the 1-year follow-up. The acute success is confirmed by catheter mapping and ECG to determine immediate ablation success rate | 15 minutes post ablation for acute sussess and one year for follow-up success |
| Incidence of intraoperative and long-term serious adverse events | The Primary endpoints for safety included the number of subjects suffering from serious adverse events. The incidence of serious adverse events related to the ablation included conduction system impairment, ventricular arrhythmia, myocardial infarction, hemolysis or major bleeding requiring transfusion, cardiac tamponade/perforation, Pericarditis requiring treatment, infectious endocarditis, valve stenosis or regurgitation deterioration, heart failure, abnormal renal and/or hepatic function, Intracerebral hemorrhage/transient ischemic attack/ stroke, and death. (Abnormal renal function (dialysis, transplant, serum creatinine >200 mmol/L); Abnormal hepatic function (cirrhosis, bilirubin > x 2 upper limit of normal, aspartate aminotransferase/alkaline phosphatase/alanine aminotransferase >3 x upper limit of normal). | 24 hours post ablation for intraoperative serious adverse events and one year for follow-up serious adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Non-serious adverse events | Muscle constraction delaying the procedure, untolerable pain or cough, abnormal renal function (without dialysisserum, creatinine <200 mmol/L), and abnormal hepatic function (cirrhosis, bilirubin < x 2 upper limit of normal, aspartate aminotransferase/alkaline phosphatase/alanine aminotransferase <3 x upper limit of normal. | 24 hours post ablation for intraoperative serious adverse events and 1 year for follow-up serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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PSVT was documented with a 12-lead surface electrocardiogram (ECG), 24-hour Holter monitoring, and esophageal electrophysiologic study (EES) before hospitalization. A diagnosis of AVNRT or AVRT was confirmed by electrophysiological study after the antiarrhythmic medications were withdrawn ≥5 half-lives. Patients with reproducibly clinical PSVT were finally enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caijie Shen, MD,PhD | Contact | 8615258258126 | shenzihai1101@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Caijie Shen | First Affiliated Hospital of Ningbo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | 315000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38801673 | Background | Shen C, Jia Z, Yu Y, Feng M, Du X, Fu G, Yu L, Wu T, Jiang Y, Jin H, Zhuo W, Gao F, Wang B, Chen S, Dai J, Fang R, Chu H. Efficacy and safety of pulsed field ablation for accessory pathways: a pilot study. Europace. 2024 Jul 2;26(7):euae139. doi: 10.1093/europace/euae139. | |
| 38242530 | Background | Shen C, Du X, Dai J, Feng M, Yu Y, Liu J, Fu G, Wang B, Jiang Y, Jin H, Chu H. Outcomes of Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia. Can J Cardiol. 2024 Jul;40(7):1294-1303. doi: 10.1016/j.cjca.2023.12.037. Epub 2024 Jan 17. |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Focal Radiofrequecy Ablation (RFA) | Procedure | Patients in the PFA group underwent ablation procedures utilizing force-sensing RFA catheters for the treatment of PSVT. |
|
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |