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Peripheral subcutaneous field stimulation for angina pectoris


- candidate number21723
- NTR NumberNTR5039
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-feb-2015
- Secondary IDsFree RAP 1 
- Public TitlePeripheral subcutaneous field stimulation for angina pectoris
- Scientific TitleFeasibility, safety and efficacy of the Freedom Stimulation System for Peripheral subcutaneous field stimulation (PSFS) application in patients with chronic refractory angina pectoris. A Pilot Study
- ACRONYM
- hypothesisThe primary objective is to determine the efficacy of angina control with this type of Peripheral Subcutaneous Field Stimulation (PSFS) at three months and 12 months. This will be assessed in a patient diary by the number of angina attacks and the required doses of nitrates in the week before the scheduled control visit. The secondary objectives determined at both 3 and 12 months are the assessment of the safety of the procedure, indicated by any intraoperative and postoperative complications such as bleeding, infection, lead migration and other technical problems. Furthermore the feasibility of the implantation and burdens for the patient (such as need for frequent re-programming) will be assessed. Based on the available literature we expect to find at least 50% reduction in angina complaints and subsequent use of short acting nitrate intake
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria-stable angina pectoris, Canadian Cardiovascular Society scale (CCS) class III- IV - therapeutic refractory for at least 3 months -angina in the retrosternal and precordial area -angiographically documented coronary artery disease -demonstrated ischemia (by exercise test, 48h ECG registration, nuclide scan or PET) -optimal anti-angina medication for ≥ 1 month - age ≥ 18 years
- Exclusion criteria-Short life expectancy (i.e. < 1 year) -Cardiac syndrome X (i.e. small vessel disease or microvascular angina pectoris) -Vaso-spastic angina pectoris -Myocardial infarction  3 months. -Severe heart failure NYHA class III-IV -Significant valve insufficiency (grade IV/IV) or valve stenosis -Treatment with TENS in the 2 weeks prior to start of the study (i.e. PSFS implantation) - Severe cutaneous sensory disturbances such as allodynia, hypoesthesia in area where angina is experienced. - skin infections in the area where angina is felt -Child bearing potential -Inability to perform exercise tests -Pacemaker dependency. -Inadequately regulated hypertension -Inadequately regulated diabetes mellitus -Psychological inability that may lead to significant instruction or compliance-problems -Inappropriate use of drugs (opiates, cocaine etc) or alcohol by the patient. -The presence of other neurostimulation device(s)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2015
- planned closingdate1-jun-2016
- Target number of participants12
- InterventionsPatients will receive up to three subcutaneous electrodes (Freedom-4®) in order to cover the area of their angina complaints
- Primary outcomeNumber of angina attacks and use of glyceryl trinitate (GTN) at baseline, 3 months and 12 months
- Secondary outcome•Subject satisfaction, measured by a 5-point subject satisfaction Likert-scale and Patient Global Impression of Change (PGIC), at baseline, 3 months and 12 months •Quality of life (measured by Seattle angina questionnaire), at baseline, 3 months and 12 months •Standardized bicycle exercise stress testing, at baseline and at 3 months: •Feasibility of the Freedom implantation procedure (duration of the procedure, patients acceptance) •Safety: number of adverse and serious adverse events, device related complications requiring medical intervention, hematomas, infections, dislodgements, loss of stimulation or device related re-hospitalization at 3 months and 12 months
- Timepoints12 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R. Spanjersberg
- CONTACT for SCIENTIFIC QUERIESBa. B. Groen
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD26-feb-2015 - 15-apr-2015


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