Outcomes of PFA Vs. RFA for Patients with PSVT: a Retrospective and Propensity Score Matching Study
- Conditions
- Catheter AblationParoxysmal Supraventricular Tachycardia
- Interventions
- Procedure: Focal Pulsed Field Ablation (PFA)Procedure: Focal Radiofrequecy Ablation (RFA)
- Registration Number
- NCT06573853
- Lead Sponsor
- Caijie Shen
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 428
- Patients with symptomatic PSVT including: atrioventricular nodal re-entrant tachycardia (AVNRT), atrioventricular re-entrant tachycardia (AVRT);
- Age range: 18 years old ≤ age ≤ 80 years old, with no gender restriction;
- Willing to receive the examinations and testings during one year follow-up required by the protocol;
- Voluntary signed informed consent.
- Organic heart disease;
- History of cardiac surgery;
- Previous failed ablation of PSVT;
- Presence of any implants, such as a permanent pacemaker;
- Patients with invasive systemic infections or advanced malignant tumors;
- Contraindications for septal puncture or retrograde transaortic access surgery;
- Any condition that makes the use of heparin or aspirin inappropriate;
- Pregnant or lactating women;
- Inability to fully comply with the study procedures and follow-ups or to provide their own informed consent;
- Coexistence with other arrhythmias, such as atrial fibrillation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PFA group Focal Pulsed Field Ablation (PFA) 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. RFA group Focal Radiofrequecy Ablation (RFA) 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.
- Primary Outcome Measures
Name Time Method Acute and long-term follow-up success rate 15 minutes post ablation for acute sussess and one year for follow-up success 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 rateIncidence of intraoperative and long-term serious adverse events 24 hours post ablation for intraoperative serious adverse events and one year for follow-up 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).
- Secondary Outcome Measures
Name Time Method Non-serious adverse events 24 hours post ablation for intraoperative serious adverse events and 1 year for follow-up 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.
Trial Locations
- Locations (1)
the First Affiliated Hospital of Ningbo University
🇨🇳Ningbo, Zhejiang, China