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A prospective, multicenter study on the safety and efficacy of pulsed field ablation and radiofrequency ablation in the treatment of paroxysmal supraventricular tachycardia

A prospective, multicenter study on the safety and efficacy of pulsed field ablation and radiofrequency ablation in the treatment of paroxysmal supraventricular tachycardia (Prosafe PSVT study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085271
Enrollment
Unknown
Registered
2024-06-04
Start date
2022-10-18
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

paroxysmal supraventricular tachycardia

Interventions

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.18 years old = age = 75 years old 2.Patients with paroxysmal supraventricular tachycardia (AV reentrant tachycardia, atrioventricular nodal reentrant tachycardia, pre-excitation syndrome) who are scheduled to undergo catheter ablation treatment 3.Those who agree to participate in this study and voluntarily sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients who have previously undergone cardiac catheter ablation. 2. Patients confirmed to have other types of arrhythmias (e.g., ventricular arrhythmias, atrial flutter, atrial fibrillation) prior to intraoperative electrophysiological examination. 3. Patients with a left ventricular ejection fraction (LVEF) =40%. 4. Patients with confirmed intracardiac thrombus or diagnosed myxoma prior to surgery. 5. Patients with New York Heart Association (NYHA) functional classification III-IV. 6. Patients with an implanted pacemaker or cardioverter-defibrillator. 7. Patients who have undergone aortic valve replacement and require ablation via the retrograde transaortic approach during surgery. 8. Patients who have undergone atrial septal repair and require transseptal puncture for ablation during surgery. 9. Patients with active systemic infection deemed unsuitable for interventional treatment by the investigator. 10. Patients with a significant bleeding tendency that precludes surgery. 11. Patients with significant hepatic or renal dysfunction (ALT/AST, Cr levels >2 times the upper limit of normal) deemed unsuitable for surgery by the investigator. 12. Patients who have experienced myocardial infarction or undergone any cardiac interventional procedures (excluding coronary angiography) or open-heart surgery within the past 90 days. 13. Patients who have experienced a symptomatic stroke or other severe cerebrovascular events within the past 90 days. 14. Patients with a history of malignancy or terminal illness that would complicate treatment and evaluation. 15. Pregnant or lactating women, or those planning to conceive during the study period. 16. Patients currently participating in other clinical trials involving drugs or medical devices. 17. Patients deemed unsuitable for participation in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Immediate success rate;

Secondary

MeasureTime frame
6 months after operation success rate;Adverse events occurring at any time during surgery and within six months postoperatively;

Countries

China

Contacts

Public ContactZeng Rui

West China Hospital, Sichuan University

zengrui_0524@126.com+86 189 8060 6560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026