CardioFit™ for the Treatment of Heart Failure

This study has been completed.
Sponsor:
Information provided by:
BioControl Medical
ClinicalTrials.gov Identifier:
NCT00461019
First received: April 16, 2007
Last updated: March 4, 2011
Last verified: March 2011
  Purpose

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 therapy, it remains a significant public health problem.

Pharmacologic antagonism of the beta-adrenergic receptors shifting the autonomic balance in the direction of greater vagal influence is a well-proven treatment for heart failure patients, although there are patients who cannot tolerate, or only partially benefit from such a treatment.

It has been proven in the past and well established that parasympathetic nerve stimulation can slow the rate of the heart and reduce the workload of the heart. Therefore, the potential benefit of vagus nerve stimulation, hence parasympathetic activation, for treatment of heart failure is substantial.

In this study, the safety and efficacy of a new vagus nerve stimulating system will be evaluated. This study will compare whether the new device improves Heart Failure parameters in Class II - III Heart Failure patients.


Condition Intervention Phase
Heart Failure
Procedure: Implantation and activation of the vagus nerve stimulator
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CardioFiT™ for Heart Failure - Safety and Efficacy Study Protocol

Resource links provided by NLM:


Further study details as provided by BioControl Medical:

Primary Outcome Measures:
  • The occurrence of all system and/or procedure related adverse events. [ Time Frame: along the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in NYHA class [ Time Frame: At 6-months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: At 6-months ] [ Designated as safety issue: No ]
  • Exercise capacity (by 6-min walk) [ Time Frame: At 6-months ] [ Designated as safety issue: No ]
  • LV Ejection fraction [ Time Frame: At 6-months ] [ Designated as safety issue: No ]
  • LV end-systolic and end-diastolic volumes [ Time Frame: At 6-months ] [ Designated as safety issue: No ]
  • Blood tests. [ Time Frame: At 6-months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: February 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implantation of the CardioFit system Procedure: Implantation and activation of the vagus nerve stimulator
Implantation of the nerve stimulator, cuff nerve electrode and RV sensing lead

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 patients Heart Failure parameters.
  • Tested hypothesis: Thirty patients are required to provide 80% power at 95% confidence level in order to detect 12 points difference on a quality of life questionnaire between pre- and post activation.
  • Design: Prospective, self-controlled interventional study composed of 5 periods: Pre-implantation, Implantation, Device activation, Follow-up (with active device) and post-study extension period.
  • Study duration is 7.5-months per patient. At the end of the study, patients enter an extension period (with active devices) during which they will be monitored for quality of life and survival, for up to 3 years post-implantation in 6-months intervals.
  • Study Endpoints:

    • Primary endpoints: The occurrence of all system and/or procedure related adverse events.
    • Secondary endpoints: changes in the following individual variables as well as in a composite score of individual variables change: NYHA class; Quality of Life; Exercise capacity (by 6-min walk); LV Ejection fraction; LV end-systolic and end-diastolic volumes; blood tests.
  • Up to 10 participating centers in Europe, Israel and Australia
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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;
  2. Age between 18 and 75 years;
  3. 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;
  4. Patient must sign an approved informed consent form. Patient agrees to attend all follow-up evaluations;
  5. 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;
  6. Patient should be in optimal medical treatment with no change in treatment in the previous 3 months with the exception of diuretics;
  7. Left ventricular ejection fraction estimated by echocardiography, cardiac angiography, radionuclide study, or other accepted mode of evaluation, is no more than 35%;
  8. Patient is physically capable and willing to perform repeated physically demanding tests associated with the study.

Exclusion Criteria:

  1. Presence of an immediately life threatening condition or disease other than heart failure, such as cancer, terminal renal failure etc.
  2. Acute myocardial Infarction (MI), variant angina pectoris, unstable angina or acute coronary syndrome in the previous three months;
  3. Previous stroke;
  4. Coronary Artery Bypass Surgery (CABG) or Percutaneous Coronary Intervention in the past 3 months;
  5. Episode of NYHA class IV heart failure, including acute pulmonary oedema in the previous three months;
  6. Heart failure due to acute myocarditis. Restrictive or constrictive pericarditis, haemodynamically significant aortic valve insufficiency aortic stenosis, or mitral valve stenosis;
  7. Severe renal or hepatic failure (Creatinine level>3 mg% (265 micromole/liter) or transaminase level four times ULN);
  8. Diabetes Mellitus treated with insulin for more than two years prior to study entry;
  9. Diabetic neuropathy;
  10. Previous neck surgery, including for Peripheral Vascular Disease (PVD), malignancy, and previous irradiation therapy of the neck;
  11. Current hypotension (systolic blood pressure below 80 mmHg);
  12. Active peptic disease or history of upper GI bleeding;
  13. Asthma, severe COPD (e.g. FEV1<1.5 liter), or severe restrictive lung disease;
  14. 1st degree AV block with PR interval > 240msec, 2nd or 3rd degree AV block;
  15. Atrial fibrillation or flutter in the in the previous 3 months;
  16. Sustained ventricular tachyarrhythmia with hemodynamic compromise, in the absence of implanted ICD;
  17. Long QT syndrome, congenital or acquired;
  18. Recorded or suspected symptomatic vaso-vagal response;
  19. Treatment by investigational drug or device within the past 3 months;
  20. Glaucoma, or history of glaucoma;
  21. Major psychiatric disorder in the present or in the past; Dementia;
  22. Patients transplanted with tissues or organs;
  23. Immunosuppressed patients; patients under systemic steroid treatment;
  24. Anemia with Hb<10gr/L, unless treated with Epo;
  25. 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;
  26. Patient is candidate for cardiac resynchronization device implantation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461019

Locations
Germany
Georg-August-Universität Göttingen
Göttingen, Germany, 37075
Otto von-Guericke University Clinik
Magdeburg, Germany, 39120
I. Medizinische Klinik, Klinikum Mannheim GmbH Universitätsklinikum Fakultät für klinische Medizin Mannheim der Universität Heidelberg
Mannheim, Germany, 68167
Italy
Fondazione IRCCS Policlinico "San Matteo"
Pavia, Italy, 27100
Netherlands
Academic Hospital Maastricht
Maastricht, Netherlands, 6202 AZ
Serbia
Pacemaker center, Cardiovascular institute Clinical Center of Serbia
Belgrade, Serbia, 11000
Sponsors and Collaborators
BioControl Medical
Investigators
Principal Investigator: Peter J Schwartz, Professor Fondazione IRCCS Policlinico San-Matteo