Outcomes of PFA Vs. RFA for Patients with PSVT: a Retrospective and Propensity Score Matching Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorCaijie Shen
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Organic heart disease;
History of cardiac surgery;
Previous failed ablation of PSVT;
Presence of any implants, such as a permanent pacemaker;
Trial 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 A diagnosis of AVNRT or AVRT was confirmed by electrophysiological study after the antiarrhythmic medications were withdrawn ≥5 half-lives.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.
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Focal Pulsed Field Ablation (PFA)
Procedure/SurgeryPatients in the PFA group underwent ablation procedures utilizing a force-sensing PFA catheter for the treatment of PSVT.
Focal Radiofrequecy Ablation (RFA)
Procedure/SurgeryPatients in the PFA group underwent ablation procedures utilizing force-sensing RFA catheters for the treatment of PSVT.
Treatment groups
428 Participants
are divided into 2 treatment groupsGroup A: PFA group1 intervention
Group B: RFA group1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
15 minutes post ablation for acute sussess and one year for follow-up success2
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).
Time frame
24 hours post ablation for intraoperative serious adverse events and one year for follow-up serious adverse eventsSecondary outcomes
1
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.
Time frame
24 hours post ablation for intraoperative serious adverse events and 1 year for follow-up serious adverse eventsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Caijie Shen
Lead sponsor
Ningbo No. 1 Hospital
Sponsor institution
Shanghai MicroPort EP MedTech Co., Ltd.
Collaborator
Source ClinicalTrials.gov