NCT00461019

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 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2 heart-failure

Timeline
Completed

Started Feb 2007

Typical duration for phase_2 heart-failure

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

3 years

First QC Date

April 16, 2007

Last Update Submit

March 4, 2011

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • The occurrence of all system and/or procedure related adverse events.

    along the study

Secondary Outcomes (6)

  • Change in NYHA class

    At 6-months

  • Quality of Life

    At 6-months

  • Exercise capacity (by 6-min walk)

    At 6-months

  • LV Ejection fraction

    At 6-months

  • LV end-systolic and end-diastolic volumes

    At 6-months

  • +1 more secondary outcomes

Study Arms (1)

Implantation of the CardioFit system

EXPERIMENTAL
Procedure: Implantation and activation of the vagus nerve stimulator

Interventions

Implantation and activation of the vagus nerve stimulatorPROCEDURE

Implantation of the nerve stimulator, cuff nerve electrode and RV sensing lead

Implantation of the CardioFit system

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • st degree AV block with PR interval \> 240msec, 2nd or 3rd degree AV block;
  • Atrial fibrillation or flutter in the in the previous 3 months;
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Georg-August-Universität Göttingen

Göttingen, 37075, Germany

Location

Otto von-Guericke University Clinik

Magdeburg, 39120, Germany

Location

I. Medizinische Klinik, Klinikum Mannheim GmbH Universitätsklinikum Fakultät für klinische Medizin Mannheim der Universität Heidelberg

Mannheim, 68167, Germany

Location

Fondazione IRCCS Policlinico "San Matteo"

Pavia, Pavia, 27100, Italy

Location

Academic Hospital Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Pacemaker center, Cardiovascular institute Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Related Publications (2)

  • De Ferrari GM, Crijns HJ, Borggrefe M, Milasinovic G, Smid J, Zabel M, Gavazzi A, Sanzo A, Dennert R, Kuschyk J, Raspopovic S, Klein H, Swedberg K, Schwartz PJ; CardioFit Multicenter Trial Investigators. Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure. Eur Heart J. 2011 Apr;32(7):847-55. doi: 10.1093/eurheartj/ehq391. Epub 2010 Oct 28.

    PMID: 21030409RESULT

  • Schwartz PJ, De Ferrari GM, Sanzo A, Landolina M, Rordorf R, Raineri C, Campana C, Revera M, Ajmone-Marsan N, Tavazzi L, Odero A. Long term vagal stimulation in patients with advanced heart failure: first experience in man. Eur J Heart Fail. 2008 Sep;10(9):884-91. doi: 10.1016/j.ejheart.2008.07.016. Epub 2008 Aug 28.

    PMID: 18760668RESULT

Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Officials

  • Peter J Schwartz, Professor

    Fondazione IRCCS Policlinico San-Matteo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 16, 2007

First Posted

April 17, 2007

Study Start

February 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 7, 2011

Record last verified: 2011-03

Locations

IT(1)DE(3)SE(1)NL(1)