Feasibility, safety and efficacy of Subcutaneous Electrical Nerve Stimulation (SENS) in patients with chronic refractory angina pectoris. A pilot study. - SENS for refractory angina pectoris.

niversitair Medisch Centrum Groningen0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- 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)

发起方