Acute Effects of a Non Excitatory Cardial Stimulation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01789112
• Date of registration: 08/02/2013
• Prospective Registration: No
• Primary sponsor: RWTH Aachen University
• Public title: Acute Effects of a Non Excitatory Cardial Stimulation
• Scientific title: Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizer III System in Patients With Heart Failure
• Date of first enrolment: July 2012
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01789112
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Sebastian Reith, MD
• Affiliation: RWTH Aachen, Medical Departement I Univerity Hospital Aachen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

CCM Implantation

Intervention(s)

Other: Blood sample

Primary Outcome(s)

positive inotropic effects by CCM stimulation [Time Frame: 15 minutes]

Secondary ID(s)

12-032

Source(s) of Monetary Support

Please refer to primary and secondary sponsors