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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48309
Enrollment
10
Registered
2019-06-13
Start date
2020-02-21
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Angina Pectoris

Interventions

After inclusion and measurement of base line parameters burst stimulation will be programmed on the SCS device of the subjects. During 1 month treatment will be with form of stimulation, with the po

Sponsors

Diakonessenhuis Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 SCS - 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

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

Design outcomes

Primary

MeasureTime frame
Clinical effectiveness of the SCS treatment for refractory angina will be measured with the Seattle angina questionnaire (SAQ) comparing baseline conventional stimulation with burst SCS at 1 month.

Secondary

MeasureTime frame
Patient satisfaction will be measured on a 11 point Numeric Rating Scale and quality of life with the EQ5D.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)