Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizier III System in Patients With Heart Failure

This study is currently recruiting participants.
Verified February 2013 by RWTH Aachen University
Information provided by (Responsible Party):
RWTH Aachen University Identifier:
First received: February 8, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted

Electric stimulation by cardial contractility modulation (CCM)to improve contractility and physical capacity

Condition Intervention
CCM Implantation
Other: Blood sample

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizier III System in Patients With Heart Failure

Resource links provided by NLM:

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • positive inotropic effects by CCM stimulation [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CCM aggregate
Taking of 10 blood samples
Other: Blood sample
Taking of blood sample


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • planned CCM Implantation
  • systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA II, III, IV)
  • implanted pacemaker, defibrillatoror or pacemaker during CS intubation
  • written informed consent
  • open entryways

Exclusion Criteria:

  • anemia HB<8 mg/dl
  • lying CS tube or CS being not able to intubate
  • chronic atrial fibrillation or flutter
  • mechanic tricuspid valve prothesis
  • no acces via subclavian vein
  • patients with VVI pacemaker being stimulated 110%
  • idiopathic hypertrophic cardiomyopathy, restrictiv constrictiv cardiomyopathy or heart failure because of known inflammatory or infiltrative illnesses or constrictive illness
  • acute myocardial ischemia presented by angina pectoris or ECG changes under load
  • patients being hospitalized because of heart failure during the last month and have to be treated with intravenous diuretics or inotropic subtances
  • acute coronary syndrome should not be implanted for at least 3 month
  • patients with mechanic aortic or tricuspid valve
  • patients after heart transplantation
  • patients with clinical significant ectopy, defined by > 8.900 PVCs during 24 hours at beginning Holter monitoring
  • patients after hyperttensive crisis
  • patients with acute renal failure
  • EF > 35
  • patients after left ventricular pacemaker electrode
  • pregnant or breast feeding women
  • patients with heart failure after sepsis
  Contacts and Locations
Please refer to this study by its identifier: NCT01789112

Contact: Patrick Schauerte, Prof. Dr. med., MD +49 241 80 89301

Univeristy Hospital Aachen Recruiting
Aachen, North Rhine Westfalia, Germany, 52074
Contact: Patrick Schauerte, Prof. Dr. med., MD    +49 241 80 89669   
Sponsors and Collaborators
RWTH Aachen University
  More Information

No publications provided

Responsible Party: RWTH Aachen University Identifier: NCT01789112     History of Changes
Other Study ID Numbers: 12-032
Study First Received: February 8, 2013
Last Updated: February 8, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 15, 2014