DRKS00026725招募中未知
se of Vanguard reprocessed ablation catheters for pulmonary vein isolation in patients with paroxysmal atrial fibrillation - VAN-RECAP_AF
VANGUARD AG0 个研究点目标入组 165 人开始时间: 2022年1月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 165
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1. Patients with
- •drug refractory paroxysmal atrial fibrillation, or
- •paroxysmal atrial fibrillation who prefer catheter ablation as first line therapy, or
- •drug refractory persistent atrial fibrillation w/o major risk factors for AF recurrence
- •who are eligible for pulmonary vein isolation according to current guidelines
- •2. Female and male patients aged 18-85 years
- •3. Planned treatment with Vanguard-reprocessed Tacticath, Smart Touch, or Arctic Front catheters
- •4. Informed consent in writing from patient
排除标准
- •1. Patients with congenital heart disease
- •2. Patients with heart failure NYHA class > II and/or LVEF < 35%
- •3. Patients who, in the opinion of the Principal Investigator, are unlikely to comply with the protocol requirements, instructions and trial related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, psychological illness, and improbability of completing the trial.
- •4. Vulnerable Patients (e.g. patients requiring a legal representative, patients kept in detention, any service within the army, and employees of the sponsor or at an investigator site).
- •5. Pregnant women or women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
- •6. Repeat ablation after any previous PVI attempt
- •7. Patients with intracardiac thrombus
- •8. Patients who have undergone a ventriculostomy or atriotomy in the preceding four weeks
- •9. Patients with heart valve prosthesis
- •10. Patients with active systemic infection
- •11. Patients who have shown sensitivity to foreign objects in the past or who have an allergy
- •12. Patients with severe anomalies in the heart and/or blood vessels (transposition) and obstruction
- •13. Patients with myxoma of the left atrium, interatrial variations or interatrial baffle or patch
- •14. Any additional contraindications for treatment with Tacticath Quartz, Thermocool Smart Touch or Arctic Front Advance catheters, according to current IFU
- •15. Planned cardiac intervention besides AF ablation within the next 12 months
- •16. Participation in any study of an investigational device or drug within 90 days prior or during this study.
研究者
相似试验
尚未招募
不适用
Vision-MR Ablation Catheter 2.0 for Treatment of Ventricular Tachycardia10007521Ventricular TachycardiaCardiac arrhythmiaNL-OMON53247Imricor Medical Systems, Inc45
进行中（未招募）
1 期
Protection offered by N-Acetylcysteine against radiation induced cellular damage in patients undergoing ablation procedures because of cardiac arrhythmia.Patients with Cardiac Arrhythmia who undergo catheter ablation procedures guided by x-Ray imagingMedDRA version: 23.1Level: LLTClassification code 10007518Term: Cardiac arrhythmiaSystem Organ Class: 100000004849EUCTR2019-001995-12-ITCENTRO CARDIOLOGICO SPA FONDAZIONE MONZINO550
招募中
不适用
Ranger drug-coated balloon catheters post market surveillanceSuperficial femoral and proximal popliteal artery diseaseJPRN-UMIN000043774Boston Scientific Japan K.K.200
已完成
不适用
Changes in the number of accidental catheter removal through the early intervention by multidisciplinary team for patients with deliriumdeliriumJPRN-UMIN000025101wajima City Hospital200
招募中
不适用
Catheter ablation of ventricular tachycardia in patients with non-ischemic cardiomyopathyVentricular tachycardia, non-ischemic cardiomyopathy, catheter ablation.NL-OMON21307eiden University Medical Center200