Catheter Ablation, Paroxysmal Supraventricular Tachycardia
Conditions
Keywords
Paroxysmal Supraventricular Tachycardia, Pulsed Field Ablation, Radiofrequency Ablation
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.
Interventions
PROCEDUREFocal Pulsed Field Ablation (PFA)
Patients in the PFA group underwent ablation procedures utilizing a force-sensing PFA catheter for the treatment of PSVT.
PROCEDUREFocal Radiofrequecy Ablation (RFA)
Patients in the PFA group underwent ablation procedures utilizing force-sensing RFA catheters for the treatment of PSVT.
Sponsors
Shanghai MicroPort EP MedTech Co., Ltd.
Caijie Shen
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 rate |
| Incidence 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactCaijie Shen, MD,PhD
Outcome results
None listed