BurstDRTM Spinal Cord Stimulation for Refractory Angina Pectoris - a pilot study
- Conditions
- Refractory Angina Pectoris
- Registration Number
- NL-OMON28539
- Lead Sponsor
- Diakonessenhuis Utrecht/Zeist
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate if BurstDRTM SCS is clinically non-inferior to conventional SCS in patients already implanted with an internal pulse generator (IPG) capable of delivering both conventional and burst SCS
- Secondary Outcome Measures
Name Time Method To evaluate patient satisfaction and quality of life with BurstDRTM SCS compared to conventional SCS. Gather data in order to calculate the adequate sample size of a future randomised controlled trial.