Outcomes of PFA Vs. RFA for Patients with PSVT: a Retrospective and Propensity Score Matching Study
NCT ID: NCT06573853
Last Updated: 2024-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
428 participants
OBSERVATIONAL
2022-10-11
2025-06-30
Brief Summary
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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.
1. Recieved PFA or RFA 1 year ago
2. Finish the visit to the clinic at 1, 3, 6, 12 months for examinations and blood testings
3. Patients recieved PFA and PFA under propensity matched comparison according to differen variety of PSVT
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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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.
Focal Pulsed Field Ablation (PFA)
Patients in the PFA group underwent ablation procedures utilizing a force-sensing PFA catheter for the treatment of PSVT.
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.
Focal Radiofrequecy Ablation (RFA)
Patients in the PFA group underwent ablation procedures utilizing force-sensing RFA catheters for the treatment of PSVT.
Interventions
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Focal Pulsed Field Ablation (PFA)
Patients in the PFA group underwent ablation procedures utilizing a force-sensing PFA catheter for the treatment of PSVT.
Focal Radiofrequecy Ablation (RFA)
Patients in the PFA group underwent ablation procedures utilizing force-sensing RFA catheters for the treatment of PSVT.
Eligibility Criteria
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Inclusion Criteria
2. Age range: 18 years old ≤ age ≤ 80 years old, with no gender restriction;
3. Willing to receive the examinations and testings during one year follow-up required by the protocol;
4. Voluntary signed informed consent.
Exclusion Criteria
2. History of cardiac surgery;
3. Previous failed ablation of PSVT;
4. Presence of any implants, such as a permanent pacemaker;
5. Patients with invasive systemic infections or advanced malignant tumors;
6. Contraindications for septal puncture or retrograde transaortic access surgery;
7. Any condition that makes the use of heparin or aspirin inappropriate;
8. Pregnant or lactating women;
9. Inability to fully comply with the study procedures and follow-ups or to provide their own informed consent;
10. Coexistence with other arrhythmias, such as atrial fibrillation.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai MicroPort EP MedTech Co., Ltd.
INDUSTRY
Caijie Shen
OTHER
Responsible Party
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Caijie Shen
Associate Chief Physician of the First Affiliated Hospital of Ningbo University
Principal Investigators
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Caijie Shen
Role: STUDY_DIRECTOR
First Affiliated Hospital of Ningbo University
Locations
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the First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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775050
Identifier Type: -
Identifier Source: org_study_id
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