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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28539

Enrollment

Registered

2020-03-01

Start date

2020-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Refractory Angina Pectoris

Interventions

The study is designed as a prospective pilot study in a cohort of patients already treated with conventional SCS and at least three months of successful treatment of refractory angina. Their device ca

Eligibility

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactFrank Wille

Amsterdam UMC

f.wille@amsterdamumc.nl+31610075250

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)