Study to Evaluate Safety of Cardiac Pacemakers in MR Imaging at 3T Tesla
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 1
研究概览
简要总结
To evaluate short-term and long-term effects by MR imaging at 3T on the technical and functional status of cardiac pacemakers.
详细描述
Recently, a shift could be observed from cardiac pacemakers being an absolute contraindication to being a relative contraindication for MR imaging at 1.5 Tesla, depending on a patient-per-patient risk-benefit-evaluation, which includes an urgent clinical need for MR imaging (other imaging modalities non-conclusive) and co-morbidities (especially cardiac co-morbidities). At the same time, MR imaging at 3 Tesla is evolving from a research application only to an important imaging modality today.
Using the improved signal-to-noise-ratio, high field MR-Systems with a field strength of 3 Tesla offer a variety of diagnostic advantages to 1.5 Tesla systems. These advantages lead to a higher sensitivity and specificity in diagnosing, foremost neurological, disorders.
In this study, we evaluate the safety of MR imaging of the brain in patients with cardiac pacemakers at 3T.
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urgent need for an MRI examination
- •Stable pacemaker physical parameters
- •Battery voltage > 2.7 V
- •Battery impedance < 2000 Ohm
- •Battery estimated remaining lifetime > 6 months
- •Lead impedances 200-2000 Ohm
- •Stable pacing parameters
- •Pacing capture threshold <2.5V at a pulse duration of 0.4ms
- •Sensing > 5mV
- •Minimum 3 months since pacemaker and lead implantation
排除标准
- •History of ventricular tachycardia (VT) or ventricular fibrillation
- •Unstable angina
- •Myocardial infarction within the previous 3 months
- •Cardiothoracic surgery within the previous 3 months
- •Presence of an abdominal pacemaker with lead length > 70 cm
- •Presence of MRI incompatible bioimplants or other MRI incompatible materials