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
1 other identifier
interventional
13
1 country
1
Brief Summary
Electric stimulation by cardial contractility modulation (CCM)to improve contractility and physical capacity
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 8, 2013
CompletedFirst Posted
Study publicly available on registry
February 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedJuly 6, 2018
July 1, 2018
5 years
February 8, 2013
July 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
positive inotropic effects by CCM stimulation
15 minutes
Study Arms (1)
CCM aggregate
EXPERIMENTALTaking of 10 blood samples
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univeristy Hospital Aachen
Aachen, North Rhine Westfalia, 52074, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Reith, MD
RWTH Aachen, Medical Departement I Univerity Hospital Aachen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2013
First Posted
February 11, 2013
Study Start
July 1, 2012
Primary Completion
June 30, 2017
Study Completion
June 30, 2017
Last Updated
July 6, 2018
Record last verified: 2018-07