NL-OMON39773已完成不适用
A prospective, randomized, multicenter, interventional study to evaluate the safety and effectiveness of the TactiCath® percutaneous ablation catheter for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation - Toccastar
St. Jude Medical GVA Sàrl0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- 18 至 99（—）
入选标准
- •1. Patient is planned to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I-IV antiarrhythmic drug
- •2. Minimum of one episode of PAF greater than 30 seconds in duration within 12 months prior to enrollment documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device
- •3. Minimum of 3 episodes of PAF within the preceding 12 months documented by patient history
- •4. Patient is 18 years of age or older
- •5. Patient is willing and capable of complying unassisted with the study protocol requirements including all specified follow up visits
- •6. Patient provides written informed consent prior to enrollment in the study
排除标准
- •1. Persistent or long-standing persistent atrial fibrillation (AF)
- •2. Patient has had 4 or more cardioversions in the last 12 months
- •3. Active systemic infection
- •4. Presence of implantable cardiac defibrillator (ICD)
- •5. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months
- •6. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months
- •7. Left atrial diameter > 5.0 cm
- •8. Left ventricular ejection fraction < 35%
- •9. New York Heart Association (NYHA) class III or IV
- •10. Previous left atrial ablation procedure, either surgical or catheter ablation
- •11. Patient has had a left atrial surgical procedure or incision with resulting scar
- •12. Previous tricuspid or mitral valve replacement or repair
- •13. Heart disease in which corrective surgery is anticipated within 6 months
- •14. Bleeding diathesis or suspected pro coagulant state
- •15. Contraindication to long term antithromboembolic therapy
- •16. Presence of condition that precludes appropriate vascular access
- •17. Renal failure requiring dialysis
- •18. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
- •19. Contraindication to computed tomography and magnetic resonance angiography
- •20. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- •21. Positive pregnancy test results for female patient of childbearing potential
- •22. Patient has other anatomic or co morbid conditions that, in the investigator*s opinion, could limit the patient*s ability to participate in the study or to comply with follow up requirements, or impact the scientific soundness of the study results
- •23. Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this study
- •24. Patient is unlikely to survive the protocol follow up period of 12 months
研究者
相似试验
进行中（未招募）
不适用
A study Protocol for patients with relapsed osteosarcomaHigh malignancy grade of osteosarcoma relapseMedDRA version: 14.1Level: PTClassification code 10031296Term: Osteosarcoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-001010-42-ITITALIAN SARCOMA GROUP
尚未招募
3 期
A multicentre prospective randomised intervention study to investigate computer assisted total knee arthroplasty (TKA) in severe knees.total knee replacement1002321310005944NL-OMON31585Stryker Howmedica20
进行中（未招募）
1 期
A study to compare the effects and safety of gadoquatrane with an already used available contrast agent for MRI tests in people with any known or suspected problems (except brain or spinal cord-related problems)Contrast enhancement in magnetic resonance imaging for assessment of non-central nervous system pathologyMedDRA version: 20.0Level: LLTClassification code: 10051174Term: Peripheral nerve disorder NOS Class: 10029205MedDRA version: 22.1Level: PTClassification code: 10078223Term: Magnetic resonance imaging Class: 100000004848MedDRA version: 22.1Level: LLTClassification code: 10029820Term: Nuclear magnetic resonance imaging gadolinium-enhanced Class: 10022891CTIS2022-501885-24-00Bayer AG664
进行中（未招募）
不适用
se of the corifolitropina alfa in oocyte donorsThe study is proposed to determine the level of compliance and pharmacoeconomic impact of three protocols for controlled ovarian stimulation in women participating in oocyte donation programEUCTR2014-001743-20-ESIVI Madrid
进行中（未招募）
不适用
A prospective, randomised, multicenter clinical trial investigating the reduction of Calcineurin inhibitor toxicity by means of steroid free long-term immune suppression with Ciclosporin A and Mycophenolat mofetil in children and adolescents after kidney transplantation - Recaltox-1EUCTR2007-001166-33-DEniversitaetsklinikum Erlangen-Nuernberg