Acute Effects of a Non Excitatory Cardial Stimulation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01789112

Enrollment

Registered

2013-02-11

Start date

2012-07-31

Completion date

2017-06-30

Last updated

2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CCM Implantation

Brief summary

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

Interventions

OTHERBlood sample

Taking of blood sample

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
positive inotropic effects by CCM stimulation	15 minutes

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026