chronic angina pectoris
Conditions
Interventions
Patients will receive up to three subcutaneous electrodes (Freedom-4®) in order to cover the area of their angina complaints
Sponsors
University medical center groningen
Eligibility
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of angina attacks and use of glyceryl trinitate (GTN) at baseline, 3 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| •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 | — |
Contacts
Public ContactR. Spanjersberg
Hanzeplein 1
Outcome results
None listed