longstandig chest pain due to heart vessel disease without further treatment options refractory angina pectoris
Conditions
Interventions
Placemnet of up to three electrodes subcutenously in the ventral part of the
chest where the aptient is usually having angina complaints.
Sponsors
anesthesiologie- onderzoeksbureau
Eligibility
Age
18 Years to 99 Years
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.
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 | — |
Countries
Netherlands
Outcome results
None listed