The 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…
ID
Bron
Aandoening
chronic angina pectoris
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Number of angina attacks and use of glyceryl trinitate (GTN) at baseline, 3 months and 12 months
Doel van het onderzoek
The 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
Onderzoeksopzet
12 months
Onderzoeksproduct en/of interventie
Patients will receive up to three subcutaneous electrodes (Freedom-4®) in order to cover the area of their angina complaints
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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)
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4938 |
| NTR-old | NTR5039 |
| Ander register | : Free RAP 1 |