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Recruiting NCT06573853

Outcomes of PFA Vs. RFA for Patients with PSVT: a Retrospective and Propensity Score Matching Study

— Observational Paroxysmal Supraventricular Tachycardia Catheter Ablation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Focal Pulsed Field Ablation (PFA), Focal Radiofrequecy Ablation (RFA).
Who it may be relevant to
Registry conditions: Paroxysmal Supraventricular Tachycardia, Catheter Ablation. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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

  • Procedure Focal Pulsed Field Ablation (PFA)
    Patients in the PFA group underwent ablation procedures utilizing a force-sensing PFA catheter for the treatment of PSVT.
  • Procedure Focal Radiofrequecy Ablation (RFA)
    Patients in the PFA group underwent ablation procedures utilizing force-sensing RFA catheters for the treatment of PSVT.

Primary outcome measures

  • Acute and long-term follow-up success rate [Time frame: 15 minutes post ablation for acute sussess and one year for follow-up success]
  • 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]
Secondary outcome measures (1)
  • Non-serious adverse events [Time frame: 24 hours post ablation for intraoperative serious adverse events and 1 year for follow-up serious adverse events]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • the First Affiliated Hospital of Ningbo University — Ningbo

Publications

  • Shen C, Jia Z, Yu Y, Feng M, Du X, Fu G, Yu L, Wu T, Jiang Y, Jin H, Zhuo W, Gao F, Wang B, Chen S, Dai J, Fang R, Chu H. Efficacy and safety of pulsed field ablation for accessory pathways: a pilot study. Europace. 2024 Jul 2;26(7):euae139. doi: 10.1093/europace/euae139. PMID 38801673
  • Shen C, Du X, Dai J, Feng M, Yu Y, Liu J, Fu G, Wang B, Jiang Y, Jin H, Chu H. Outcomes of Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia. Can J Cardiol. 2024 Jul;40(7):1294-1303. doi: 10.1016/j.cjca.2023.12.037. Epub 2024 Jan 17. PMID 38242530

Identifiers

NCT: NCT06573853 · 775050

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗