Feasibility, safety and efficacy of Subcutaneous Electrical Nerve Stimulation (SENS) in patients with chronic refractory angina pectoris. A pilot study.
- Conditions
- angina pectorischest pain10082206
- Registration Number
- NL-OMON33732
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- stable angina pectoris, Canadian Cardiovascular Society (CCS) scale, class III-IV, therapeutic refractory for at least 3 months
- anginal pain 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-anginal medication for >= 1 month
- age >= 18 years
- 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.SENS implantation)
- Skin-sensibility disorders in anginal area
- Child bearing potential
- Inability to perform exercise tests
- Pacemaker dependency.
- Inadequately regulated hypertension
- Inadequately regulated diabetes mellitus
- Psychological inability which can cause significant instruction or compliance-problems
- Inappropriate use of drugs (opiates, cocaine etc) or alcohol by the patient.
- The presence of other neurostimulation device(s)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method