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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Sponsor
- Caijie Shen
- Enrollment
- 428
- Locations
- 1
- Primary Endpoint
- Acute and long-term follow-up success rate
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
- Recieved PFA or RFA 1 year ago
- Finish the visit to the clinic at 1, 3, 6, 12 months for examinations and blood testings
- 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.
Investigators
Caijie Shen
Associate Chief Physician of the First Affiliated Hospital of Ningbo University
Ningbo No. 1 Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Acute and long-term follow-up success rate
Time Frame: 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 rate
Incidence of intraoperative and long-term serious adverse events
Time Frame: 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 Outcomes
- Non-serious adverse events(24 hours post ablation for intraoperative serious adverse events and 1 year for follow-up serious adverse events)