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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
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01789112
First received: February 8, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted

February 8, 2013
February 8, 2013
May 2012
July 2013   (final data collection date for primary outcome measure)
positive inotropic effects by CCM stimulation [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
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Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizier III System in Patients With Heart Failure
Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizier III System in Patients With Heart Failure

Electric stimulation by cardial contractility modulation (CCM)to improve contractility and physical capacity
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
CCM Implantation
Other: Blood sample
Taking of blood sample
Experimental: CCM aggregate
Taking of 10 blood samples
Intervention: Other: Blood sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Patrick Schauerte, Prof. Dr. med., MD +49 241 80 89301 pschauerte@ukaachen.de
Germany
 
NCT01789112
12-032
Not Provided
RWTH Aachen University
RWTH Aachen University
Not Provided
Not Provided
RWTH Aachen University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP