Status:
COMPLETED
CardioFit™ for the Treatment of Heart Failure
Lead Sponsor:
BioControl Medical
Conditions:
Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Congestive Heart Failure is the result of a number of diseases affecting the heart, causing the heart's failure to properly meet the body demands for blood circulation. In spite of advances in drug th...
Detailed Description
* Purpose of the study: To determine the safety and efficacy of the CardioFit™ system for treatment of Class II-III Heart Failure patients. * Study hypothesis: CardioFit system treatment will improve ...
Eligibility Criteria
Inclusion
- The patient is in chronic heart failure, NYHA II-III. The patient may have been previously in class IV but must be in class II or III for three or more months prior to study entry;
- Age between 18 and 75 years;
- The patient is a male or postmenopausal female. Females of childbearing age may be included if pregnancy is excluded and acceptable contraception measures are used;
- Patient must sign an approved informed consent form. Patient agrees to attend all follow-up evaluations;
- Patient should be in sinus rhythm. Average 24-hour heart rate is between 60 and 110 b/min in a recorded 24-h Holter measurement;
- Patient should be in optimal medical treatment with no change in treatment in the previous 3 months with the exception of diuretics;
- Left ventricular ejection fraction estimated by echocardiography, cardiac angiography, radionuclide study, or other accepted mode of evaluation, is no more than 35%;
- Patient is physically capable and willing to perform repeated physically demanding tests associated with the study.
Exclusion
- Presence of an immediately life threatening condition or disease other than heart failure, such as cancer, terminal renal failure etc.
- Acute myocardial Infarction (MI), variant angina pectoris, unstable angina or acute coronary syndrome in the previous three months;
- Previous stroke;
- Coronary Artery Bypass Surgery (CABG) or Percutaneous Coronary Intervention in the past 3 months;
- Episode of NYHA class IV heart failure, including acute pulmonary oedema in the previous three months;
- Heart failure due to acute myocarditis. Restrictive or constrictive pericarditis, haemodynamically significant aortic valve insufficiency aortic stenosis, or mitral valve stenosis;
- Severe renal or hepatic failure (Creatinine level\>3 mg% (265 micromole/liter) or transaminase level four times ULN);
- Diabetes Mellitus treated with insulin for more than two years prior to study entry;
- Diabetic neuropathy;
- Previous neck surgery, including for Peripheral Vascular Disease (PVD), malignancy, and previous irradiation therapy of the neck;
- Current hypotension (systolic blood pressure below 80 mmHg);
- Active peptic disease or history of upper GI bleeding;
- Asthma, severe COPD (e.g. FEV1\<1.5 liter), or severe restrictive lung disease;
- 1st degree AV block with PR interval \> 240msec, 2nd or 3rd degree AV block;
- Atrial fibrillation or flutter in the in the previous 3 months;
- Sustained ventricular tachyarrhythmia with hemodynamic compromise, in the absence of implanted ICD;
- Long QT syndrome, congenital or acquired;
- Recorded or suspected symptomatic vaso-vagal response;
- Treatment by investigational drug or device within the past 3 months;
- Glaucoma, or history of glaucoma;
- Major psychiatric disorder in the present or in the past; Dementia;
- Patients transplanted with tissues or organs;
- Immunosuppressed patients; patients under systemic steroid treatment;
- Anemia with Hb\<10gr/L, unless treated with Epo;
- Patients who are at risk for carotid arteries plaques and have unstable carotid plaques, as assessed by Echo Doppler; and/or patients with \>70% carotid artery stenosis;
- Patient is candidate for cardiac resynchronization device implantation.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00461019
Start Date
February 1 2007
End Date
February 1 2010
Last Update
March 7 2011
Active Locations (6)
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1
Georg-August-Universität Göttingen
Göttingen, Germany, 37075
2
Otto von-Guericke University Clinik
Magdeburg, Germany, 39120
3
I. Medizinische Klinik, Klinikum Mannheim GmbH Universitätsklinikum Fakultät für klinische Medizin Mannheim der Universität Heidelberg
Mannheim, Germany, 68167
4
Fondazione IRCCS Policlinico "San Matteo"
Pavia, Pavia, Italy, 27100