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

This study is currently recruiting participants.

Verified February 2013 by RWTH Aachen University

Sponsor:

Information provided by (Responsible Party):

RWTH Aachen University

ClinicalTrials.gov Identifier:

NCT01789112

First received: February 8, 2013

Last updated: NA

Last verified: February 2013

History: No changes posted

Purpose

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

Condition	Intervention
CCM Implantation	Other: Blood sample

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizier III System in Patients With Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:

positive inotropic effects by CCM stimulation [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2012
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CCM aggregate Taking of 10 blood samples	Other: Blood sample Taking of blood sample

Eligibility

Criteria

Inclusion Criteria:

planned CCM Implantation
systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA II, III, IV)
implanted pacemaker, defibrillatoror or pacemaker during CS intubation
written informed consent
open entryways

Exclusion Criteria:

anemia HB<8 mg/dl
lying CS tube or CS being not able to intubate
chronic atrial fibrillation or flutter
mechanic tricuspid valve prothesis
no acces via subclavian vein
patients with VVI pacemaker being stimulated 110%
idiopathic hypertrophic cardiomyopathy, restrictiv constrictiv 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 subtances
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 hyperttensive crisis
patients with acute renal failure
EF > 35
patients after left ventricular pacemaker electrode
pregnant or breast feeding women
patients with heart failure after sepsis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789112

Contacts

Contact: Patrick Schauerte, Prof. Dr. med., MD

+49 241 80 89301

Locations

Germany
Univeristy Hospital Aachen	Recruiting
Aachen, North Rhine Westfalia, Germany, 52074
Contact: Patrick Schauerte, Prof. Dr. med., MD +49 241 80 89669 pschauerte@ukaachen.de

Sponsors and Collaborators

RWTH Aachen University

More Information

No publications provided

Responsible Party:	RWTH Aachen University
ClinicalTrials.gov Identifier:	NCT01789112 History of Changes
Other Study ID Numbers:	12-032
Study First Received:	February 8, 2013
Last Updated:	February 8, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013