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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Acute and long-term follow-up success rate [Срок оценки: 15 minutes post ablation for acute sussess and one year for follow-up success]
• Incidence of intraoperative and long-term serious adverse events [Срок оценки: 24 hours post ablation for intraoperative serious adverse events and one year for follow-up serious adverse events]

Вторичные конечные точки (1)

• Non-serious adverse events [Срок оценки: 24 hours post ablation for intraoperative serious adverse events and 1 year for follow-up serious adverse events]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

• the First Affiliated Hospital of Ningbo University — Ningbo

Публикации

• 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

Идентификаторы

NCT: NCT06573853 · 775050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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