Clinical trial NCT06573853: Outcomes of PFA Vs. RFA for Patients with PSVT: a Retrospective and Propensity Score Matching Study
Official title: The Safety and Efficiency of Pulsed Field Ablation and Radiofrequency Ablation in the Treatment of Paroxysmal Supraventricular Tachycardia：a Retrospective and Propensity Score Matching Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Paroxysmal Supraventricular Tachycardia
Catheter Ablation
Keywords: Paroxysmal Supraventricular Tachycardia
Pulsed Field Ablation
Radiofrequency Ablation
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai MicroPort EP MedTech Co., Ltd.
First posted: 2024-08-27
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 A diagnosis of AVNRT or AVRT was confirmed by electrophysiological study after the antiarrhythmic medications were withdrawn ≥5 half-lives.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.

Brief summary: 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.

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with symptomatic PSVT including: atrioventricular nodal re-entrant tachycardia (AVNRT), atrioventricular re-entrant tachycardia (AVRT);
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:

1. Organic heart disease;
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.

Primary outcomes:
measure: Acute and long-term follow-up success rate
timeFrame: 15 minutes post ablation for acute sussess and one year for follow-up success
measure: Incidence of intraoperative and long-term serious adverse events
timeFrame: 24 hours post ablation for intraoperative serious adverse events and one year for follow-up serious adverse events
Secondary outcomes:
measure: Non-serious adverse events
timeFrame: 24 hours post ablation for intraoperative serious adverse events and 1 year for follow-up serious adverse events
Other outcomes:
Locations:
city: Ningbo
country: China
facility: the First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Ningbo University
name: Caijie Shen
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.