NCT02175797已完成不适用
Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System
MicroPort CRM2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2014年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer.
研究概览
简要总结
The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who is already implanted with following system KORA 100 (SR or DR) pacemaker and Beflex RF45D and/or RF46D pacing leads in the left or right pectoral region
- •Patient who is able and willing out-of-chest non medical indicated MRI scanning OR patients with planned medical indicated out of chest MRI scanning
- •Patient who fulfils MRI solutions conditions
- •Patient who provides signed and dated informed consent
排除标准
- •Implanted or planned to be implanted non MR-compatible device or material
- •Permanent Atrial Fibrillation (for DR devices)
- •Diaphragmatic/phrenic stimulation
- •Claustrophobia
- •Incessant ventricular tachyarrhythmia
- •Inability to understand the purpose of the study or refusal to co-operate
- •Unavailability for scheduled follow-ups at the implanting centre
- •Already included in another clinical trial that could affect the results of this study
- •Patient is minor (less than 18-years old)
- •Patient is pregnant - Patient is forfeiture of freedom or under guardianship
研究组 & 干预措施
Pacemaker + leads
Other
all patients must have a MRI exam after pacemaker implantation
干预措施: MRI (Device)
结局指标
主要结局
Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer.
时间窗: 1 month
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
Assessment of myocardial viability in MRI: Comparison of Late Gadolinium Enhancement with Gadovist vs. Magnevist vs. Dotarem - Cardiac LGEPatients with a history of chronic myocardial infarctionMedDRA version: 12.1Level: LLTClassification code 10028596Term: Myocardial infarctionMedDRA version: 12.1Level: LLTClassification code 10028598Term: Myocardial infarction oldMedDRA version: 12.1Level: LLTClassification code 10028599Term: Myocardial infarction old healedMedDRA version: 12.1Level: LLTClassification code 10030272Term: Old myocardial infarctionEUCTR2009-017739-17-DECharité40
已完成
不适用
Cardiac Magnetic Resonance Imaging and echocardiography in the detection of cardiotoxicity in cancer patients: A feasibility studyCardiac dysfunctionIntra-thoracic cancerOesophageal cancerChemotherapy related toxicityRadiotherapy related toxicityCardiovascular - Normal development and function of the cardiovascular systemCardiovascular - Other cardiovascular diseasesCancer - BreastBreast CancerLymphomaleukaemiaACTRN12615001238561iverpool Hospital44
已完成
不适用
Control Post Endovascular Treatment of Aortic Aneurisms Through Magnetic Resonance and Ultrasound (SAFEVAR)Abdominal Aortic AneurismNCT03439423IRCCS Policlinico S. Donato250
已完成
不适用
Validation of MRI measurements in myocardial biopsiesCardiac muscle disease10028593cardiomyopathyNL-OMON47680Academisch Medisch Centrum50
Unknown
不适用
Stress Cardiac MRI in Ischemic PatientsIschemic CardiomyopathyNCT04588675Assiut University50