A Clinical Study on the Use of a Domestically Produced Three-dimensional Cardiac Electrophysiological Mapping System Combined With Pressure Monitoring Technology and Star Mapping Technology for the Treatment of Paroxysmal Atrial Fibrillation.

Обзор

Validating the safety and efficacy of pressure monitoring technology and star-shaped marking technology for the treatment of paroxysmal atrial fibrillation

Подробное описание

This trial will select appropriate clinical cases at clinical centres, where authorised investigators will perform ablation surgery for paroxysmal atrial fibrillation using the trial product. Indicators such as immediate ablation success rate and treatment success rate within three months post-surgery will be collected.

Вмешательства

• Устройство FireMagic™ Magbot Ablation Catheter 、FireMagic™ TrueForce™ Ablation Catheter
  1. The pressure-sensing catheter primarily consists of electrodes, a catheter body, and a control handle. The catheter body comprises a high-torque body and a flexible tip, divided into an adjustable bending segment and a main segment. By pushing or pulling the handle at the proximal end of the catheter, the internal traction wire at the catheter tip can be activated to control the bending of the tip. The adjustable bending segment is fixed with four electrodes at regular intervals, including on

Первичные конечные точки

• Three-month follow-up success rate after surgery [Срок оценки: Postoperative 3-month]

Вторичные конечные точки (1)

• Immediate ablation success rate [Срок оценки: On the day of the surgery]

Критерии участия

Критерии включения

• Patient age between 18 and 80 years old, male or non-pregnant female.
• Confirmed diagnosis of paroxysmal atrial fibrillation requiring catheter radiofrequency ablation surgery.
• Fully understands the treatment plan and voluntarily signs the informed consent form, willing to undergo the examinations, surgery, and follow-up required by the plan.

Критерии исключения

• Post-ablation for atrial fibrillation
• Reproductive-age patients who cannot use effective contraception within 12 months of enrolment
• Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%
• Left atrial thrombus
• History of atrial septal defect repair or atrial myxoma
• History of cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack)
• History of cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision)
• Patients with acute or severe systemic infection
• Patients with severe liver or kidney disease
• Patients with significant bleeding tendencies or haematological disorders
• Patients with malignant tumours or end-stage diseases
• Patients deemed ineligible for this trial by the investigator

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• West China Hospital of Sichuan University — Чэнду

Идентификаторы

NCT: NCT07039032 · A.1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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