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OpenTrials
Completed

NCT Number: NCT01789112

Acute Effects of a Non Excitatory Cardial Stimulation

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

Completed

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Key information

Conditions

CCM Implantation

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy Hospital Aachen

Aachen, North Rhine Westfalia, 52074, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

Taking of blood sample

Primary outcomes

  1. positive inotropic effects by CCM stimulation

    Time frame: 15 minutes

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Feb 11, 2013
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.