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

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

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

Study Overview

• Status: Recruiting
• Conditions: Catheter Ablation; Paroxysmal Supraventricular Tachycardia
• Intervention / Treatment: Procedure: Focal Pulsed Field Ablation (PFA); Procedure: Focal Radiofrequecy Ablation (RFA)

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.

• Study Type: Observational
• Enrollment (Estimated): 428

Contacts and Locations

• Study Contact: Name: Caijie Shen, MD,PhD; Phone Number: 8615258258126; Email: shenzihai1101@126.com

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315000
      • Recruiting
      • The First Affiliated Hospital of Ningbo University
      • Contact: Chu HuiMin; Phone Number: 0574-87085588; Email: markchu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: 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.	Procedure: Focal Radiofrequecy Ablation (RFA); Patients in the PFA group underwent ablation procedures utilizing force-sensing RFA catheters for the treatment of PSVT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Caijie Shen
• Collaborators: Shanghai MicroPort EP MedTech Co., Ltd.
• Investigators: Study Director: Caijie Shen, First Affiliated Hospital of Ningbo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Radiofrequency Ablation; Pulsed Field Ablation; Paroxysmal Supraventricular Tachycardia
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular; Tachycardia, Supraventricular
• Other Study ID Numbers: 775050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No