Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT01789112
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01789112
Study Brief:
Protocol Section:
NCT01789112