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
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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, 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 ClinicalTrials.gov identifier: NCT01789112

Contacts
Contact: Patrick Schauerte, Prof. Dr. med., MD +49 241 80 89301 pschauerte@ukaachen.de

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

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on April 22, 2014