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Clinical Trials/NL-OMON48309
NL-OMON48309
Completed
Phase 4

BurstDRTM Spinal Cord Stimulation for Refractory Angina Pectoris - a pilot study - Burst-AP study/BAP study

Diakonessenhuis Utrecht0 sites10 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Refractory Angina Pectoris
Sponsor
Diakonessenhuis Utrecht
Enrollment
10
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • \- age 18 to 90 of either sex
  • \- mentally competent and able to fill in the questionnaires
  • \- implanted with an IPG capable of delivering both conventional and BurstDRTM
  • \- 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 I pod

Exclusion Criteria

  • \- 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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