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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01789112
First received: February 8, 2013
Last updated: July 8, 2014
Last verified: July 2014

February 8, 2013
July 8, 2014
May 2012
July 2015   (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
Complete list of historical versions of study NCT01789112 on ClinicalTrials.gov Archive Site
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Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizer III System in Patients With Heart Failure
Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizer III System in Patients With Heart Failure

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

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Interventional
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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 2015   (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, defibrillator or pacemaker during CS intubation
  • written informed consent
  • open entryways

Exclusion Criteria:

  • anemia Hemoglobin (HB)<8 mg/dl
  • lying coronary sinus (CS) tube or CS being not able to intubate
  • chronic atrial fibrillation or flutter
  • mechanic tricuspid valve prothesis
  • no access via subclavian vein
  • patients with VVI pacemaker being stimulated 110%
  • idiopathic hypertrophic cardiomyopathy, restrictive constrictive 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 substances
  • 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 hypertensive crisis
  • patients with acute renal failure
  • Ejection Fraction (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: Sebastian Reith, MD +49 241 80 35170 sreith@ukaachen.de
Contact: Sigrid Gloeggler, M.Sc. +49 241 80 80202 sgloeggler@ukaachen.de
Germany
 
NCT01789112
12-032
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RWTH Aachen University
RWTH Aachen University
Not Provided
Not Provided
RWTH Aachen University
July 2014

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