Outcomes of PFA Vs. RFA for Patients With PSVT: a Retrospective and Propensity Score Matching Study
NCT Number: NCT06573853
Acronym: PFA*RFA*PSVT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Paroxysmal Supraventricular Tachycardia|Catheter Ablation
Interventions: PROCEDURE: Focal Pulsed Field Ablation (PFA)|PROCEDURE: Focal Radiofrequecy Ablation (RFA)
Sponsor: Caijie Shen
Collaborators: Shanghai MicroPort EP MedTech Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 428
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-11
Completion Date: 2025-06-30
Locations: the First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, 315000, China

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

Primary Outcome Measures: 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: 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