Comparing Pulsed Field Ablation and Radiofrequency Ablation for PSVT
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
This study is testing whether pulsed field ablation or radiofrequency ablation works better for people with paroxysmal supraventricular tachycardia over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 428 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ningbo No. 1 Hospital Academic / other |
| Locations | 1 site (Ningbo, Zhejiang) |
| Trial ID | NCT06573853 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the long-term outcomes of pulsed field ablation (PFA) versus radiofrequency ablation (RFA) in patients with paroxysmal supraventricular tachycardia (PSVT). Researchers will analyze data from patients who underwent either procedure and assess their efficiency and safety during the procedure and at one-year follow-up. The study will utilize propensity score matching to ensure comparability between the two treatment groups. Patients will be required to attend follow-up visits at 1, 3, 6, and 12 months for examinations and blood tests.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with symptomatic PSVT, including AVNRT and AVRT, who are willing to participate in follow-up examinations.
Not a fit: Patients with organic heart disease, previous failed ablation, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which ablation technique is more effective and safer for treating PSVT, potentially improving patient outcomes.
How similar studies have performed: While there have been studies comparing different ablation techniques, this specific comparison of PFA and RFA in PSVT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ningbo, Zhejiang
- the First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Caijie Shen, MD,PhD
- Email: shenzihai1101@126.com
- Phone: 8615258258126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.