Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
184 participants
OBSERVATIONAL
2011-09-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Chronic heart failure
No interventions assigned to this group
CCM treatment
Subjects with heart failure receiving OPTIMIZER system implant
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Symptomatic heart failure (NYHA Class 2, 3 or 4) despite receiving optimal medical therapy with doses of medications that are stable (no more than 50 % variation) for at least 7 days.
* EF ≤ 45%
* Signed informed consent
Exclusion Criteria
* Heart failure due to a potentially correctible cause ( e. g. valvular disease, congenital disease)
* Idiopathic hypertrophic cardiomyopathy, restrictive or constrictive cardiomyopathy, or heart failure on the basis of a known inflammatory or infiltrative disease (e. g. amyloidosis, sarcoidosis) or constrictive disease
* Active ischemia or exercise tolerance limited by angina
* Hospitalizations for heart failure which required the use of inotropic support within 14 days of enrollment
* Chronic (permanent or persistent) atrial fibrillation or atrial flutter
* Scheduled for a CABG or a PCI procedure, or has undergone a CABG procedure within 90 days or a PCI procedure within 30 days of enrollment
* Myocardial infarction within 90 days of enrollment
* Hemodialysis or peritoneal dialysis
* Prior heart transplant
* Participating in another study
18 Years
ALL
No
Sponsors
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Impulse Dynamics
INDUSTRY
Stiftung Institut fuer Herzinfarktforschung
OTHER
Responsible Party
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Principal Investigators
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Andrew Remppis, Professor
Role: PRINCIPAL_INVESTIGATOR
Bad Bevensen
Locations
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CCB
Frankfurt am Main, Hesse, Germany
Countries
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Other Identifiers
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ID CP OPT2009-007
Identifier Type: -
Identifier Source: org_study_id
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