BurstDRTM Spinal Cord Stimulation for Refractory Angina Pectoris - a pilot study

Diakonessenhuis Utrecht/Zeist0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•- age 18 to 90 of either sex, successfully treated with SCS for refractory angina during at least 3 months
•- mentally competent and able to fill in the questionnaires
•- implanted with an IPG capable of delivering both conventional and BurstDRTM SCS at least 1 month before study enrolment
•- no changes in anti-angina medication in the previous three months
•- no procedures like PCI or CABG, nor instability of the clinical signs and symptoms of refractory angina in the previous three months
•- the implanted SCS system has no signs of hardware problems (normal lead impedances)
•- able to use the remote control Ipod

•Subjects who meet any of the following criteria will be excluded from participation in this study:
•- signs of instable angina pectoris
•- unexplained weight loss in the previous three months
•- inability to visit the outpatient department for the follow-up visits
•- unable to provide informed consent
•- myocardial infarction or unstable angina in the previous three months

发起方

Diakonessenhuis Utrecht/Zeist