Outcomes of PFA Vs. RFA for Patients with PSVT: a Retrospective and Propensity Score Matching Study (PFA*RFA*PSVT)

Caijie Shen

Status: Enrolling

Conditions: Paroxysmal Supraventricular Tachycardia; Catheter Ablation

Treatments: Procedure: Focal Radiofrequecy Ablation (RFA); Procedure: Focal Pulsed Field Ablation (PFA)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06573853

775050

Details and patient eligibility

About

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

Full 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.

Enrollment: 428 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

428 participants in 2 patient groups

PFA group

Description:

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.

Treatment:

Procedure: Focal Pulsed Field Ablation (PFA)

RFA group

Description:

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.

Treatment:

Procedure: Focal Radiofrequecy Ablation (RFA)