NL-OMON28539
Recruiting
Not Applicable
BurstDRTM Spinal Cord Stimulation for Refractory Angina Pectoris - a pilot study
Diakonessenhuis Utrecht/Zeist0 sites10 target enrollmentTBD
ConditionsRefractory Angina Pectoris
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractory Angina Pectoris
- Sponsor
- Diakonessenhuis Utrecht/Zeist
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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