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
  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 Optimizer 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 2015 (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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: July 8, 2014
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 July 28, 2014