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CardioFit™ for the Treatment of Heart Failure

NCT00461019 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-03-07

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Implantation and activation of the vagus nerve stimulator

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

Sponsors & Collaborators

  • BioControl Medical

    lead INDUSTRY

Principal Investigators

  • Peter J Schwartz, Professor · Fondazione IRCCS Policlinico San-Matteo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Germany
  • Italy
  • Netherlands
  • Serbia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00461019 on ClinicalTrials.gov