JPRN-jRCTs052230160招募中Unknown
A Single-Center Prospective Randomized Clinical Trial Comparing the Cooling Effect of Different Balloon Sizes of Cryoballoon Ablation in Patients with Paroxysmal Atrial Fibrillation - FIT study
Miyamoto Koji0 个研究点目标入组 240 人开始时间: 2024年1月9日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •1. Patients aged 20-85 years old
- •2. Patients diagnosed with symptomatic paroxysmal atrial fibrillation and determined by the attending physician to require catheter ablation
- •3. Patients with written informed consent
排除标准
- •1. Patients with history of catheter ablation and/or surgery of atrial fibrillation
- •2. Patients with left atrial dimension more than 55 mm
- •3. Pregnant or potentially pregnant patients
- •4. Patients with concomittant participation in intervention study with other medication and/or medical instrument
- •5. Patients with active systemic infection
- •6. Patients with atrial myxoma and/or thrombus in the heart
- •7. Patients with artificial heart valves (mechanical or bioprosthetic valves) or a MitraClip device implanted at the site where the catheter passes
- •8. Patients who have undergone ventricular or atrial surgery within the last 4 weeks before obtaining consent
- •9. Patients with pulmonary vein stents in place.
- •10. Patients with cryoglobulinemia
- •11. Patients determined that the insertion into the atrium or operations within the atrium cannot be safely performed
- •12. Patients with intra-atrial baffles, atrial septal defect patches, and/or other surgical interventions in the atrium or its vicinity
- •13. Patients with severe coagulation disorders or those who cannot tolerate anticoagulation therapy during electrophysiological procedures.
- •14. Patients for whom catheter manipulation within the cardiac chambers is considered unsafe, making invasive electrophysiological procedures contraindicated
- •15. Patients with inaccessible vascular access or occluded femoral veins
- •16. Severe renal impairment (estimated glomerular filtration rate <15 mL/min/1.73m2)
- •17. Patients who cannot undergo MRI
- •18. Patients for whom the principal investigator or co-investigator has determined that participation in the study is not appropriate.
研究者
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