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

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ClinicalTrials.gov Identifier: NCT01789112
Recruitment Status : Unknown
Verified September 2015 by RWTH Aachen University.
Recruitment status was:  Recruiting
First Posted : February 11, 2013
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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

Condition or disease Intervention/treatment Phase
CCM Implantation Other: Blood sample Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizer III System in Patients With Heart Failure
Study Start Date : May 2012
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: CCM aggregate
Taking of 10 blood samples
Other: Blood sample
Taking of blood sample




Primary Outcome Measures :
  1. positive inotropic effects by CCM stimulation [ Time Frame: 15 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789112


Contacts
Contact: Sebastian Reith, MD +49 241 80 35170 sreith@ukaachen.de
Contact: Sigrid Gloeggler, M.Sc. +49 241 80 80202 sgloeggler@ukaachen.de

Locations
Germany
Univeristy Hospital Aachen Recruiting
Aachen, North Rhine Westfalia, Germany, 52074
Contact: Sebastian Reith, MD    +49 241 80 35170    sreith@ukaachen.de   
Contact: Sigrid Gloeggler, M. Sc.    +49 241 80 80202    sgloeggler@ukaachen.de   
Sub-Investigator: Matthias Zink, MD         
Sponsors and Collaborators
RWTH Aachen University

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01789112     History of Changes
Other Study ID Numbers: 12-032
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases