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临床试验/NCT00336011
NCT00336011已完成不适用

Studie Zur Sicherheit Von Medtronic Schrittmachern Bei Magnetresonanz-Bildgebungsverfahren an 1,5 Tesla-Systemen Study to Evaluate Safety Medtronic Pacemakers in MR Imaging at 1.5T Tesla)

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2002年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
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 on the technical and functional status of Medtronic pacemakers.

详细描述

The presence of a cardiac pacemaker (PM) is currently considered an absolute contraindication to MR imaging, and most patients with PM are excluded from having MRI. In 2002 there were approximately 2.4 million patients in the US with cardiac PM, and this number is growing by 80,000 annually. A previous study has shown that MRI is indicated in 17% of all patients with pacemakers within 12 months of device placement 1, demonstrating the need for a practical and safe approach for performing MRI on PM patients.

The aim of this study is to develop a strategy for safe performance of MR imaging at 1.5T, which included exclusion of pacemaker dependent patients and those requiring imaging of the thorax, restriction of specific absorption rate (SAR) values to minimize the risk of lead heating, and PM reprogramming to avoid interference from time varying gradient fields. The safety of this approach is then evaluated in a large group of PM patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds, and performing a 3-month follow-up to evaluate long-term effects.

研究设计

研究类型
Observational
观察模型
Defined Population
时间视角
Prospective

入排标准

年龄范围
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Urgent need for an MRI examination
  • Presence of a Medtronic PM system manufactured between 1993 and 2004
  • 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

  • PM system manufacturer other than Medtronic
  • History of ventricular tachycardia (VT) or ventricular fibrillation
  • Unstable angina
  • Myocardial infarction within the previous 3 months
  • Cardiothoracic surgery within the previous 3 months
  • Complete atrioventricular block
  • Absolute pacemaker dependence
  • Heart rate < 40 bpm or
  • Heart rate < 60 bpm producing neurological symptoms
  • Presence of an abdominal pacemaker with lead length > 70 cm
  • Presence of MRI incompatible bioimplants or other MRI incompatible materials
  • Request for an MR examination of the chest, including the heart, breasts and thoracic spine

研究者

发起方
University Hospital, Bonn
申办方类型
Other

研究点 (1)

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Safety of Cardiac Pacemakers in 1.5T Tesla MRI | 临床试验