Acute Effects of a Non Excitatory Cardial Stimulation

Not Applicable

Completed

• Conditions: CCM Implantation
• Interventions: Other: Blood sample

• Registration Number: NCT01789112
• Lead Sponsor: RWTH Aachen University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-11
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-03
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CCM aggregate	Blood sample	Taking of 10 blood samples

Primary Outcome Measures

Name	Time	Method
positive inotropic effects by CCM stimulation	15 minutes

Trial Locations

Locations (1)

Univeristy Hospital Aachen; 🇩🇪 Aachen, North Rhine Westfalia, Germany