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Effects of CCM-therapy in Patients With Heart Failure (CCM-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02895048
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : September 9, 2016
Sponsor:
Collaborator:
Impulse Dynamics
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung

Study Description
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Brief Summary:
The effects of Cardiac Contractility Modulation (CCM) treatment are observed in patients with heart failure.

Condition or disease
Heart Failure

Detailed Description:
The OPTIMIZER III System is indicated for use in patients greater than 18 years of age with symptomatic heart failure due to left ventricular systolic dysfunction despite appropriate medical therapy. The study will gather additional data on the effect of CCM treatment with the objective of determining the impact of CCM on the composite of heart failure hospitalizations and mortality in the low ejection fraction (EF < 35%) and mildly reduced ejection fraction (35 ≤ EF ≤ 45) heart failure population. The study will also assess the impact of CCM on exercise tolerance (six minute hall walk test, 6 Minute Walk Test) and quality of life (Minnesota Living With Heart Failure Questionnaire, MLWHFQ) in these same populations.
Study Design
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Study Type : Observational
Actual Enrollment : 184 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical Effects of Cardiac Contractility Modulation (CCM) With the OPTIMIZER III System in Subjects With Heart Failure Caused by Left Ventricular Dysfunction
Study Start Date : September 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort
Chronic heart failure
CCM treatment
Subjects with heart failure receiving OPTIMIZER system implant


Outcome Measures
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Primary Outcome Measures :
  1. All-cause and cardiac mortality [ Time Frame: 24 Months ]

Secondary Outcome Measures :
  1. the rate of all-cause and cardiac-related hospitalizations [ Time Frame: 24 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study shall include up to 300 subjects with CCM treatment and up to 300 subjects without CCM treatment. Patients without CCM treatment serve as Control patients and they will be recruited from centers not implanting OPTIMIZER systems.
Criteria

Inclusion Criteria (treatment group):

  • Any subject who receives an OPTIMIZER system implant and provides informed consent

Exclusion Criteria (treatment group):

  • None

Inclusion Criteria (control group):

  • 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 (control group):

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895048


Locations
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Germany
CCB
Frankfurt/Main, Hesse, Germany, 29549
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Impulse Dynamics
Investigators
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Principal Investigator: Andrew Remppis, Professor Bad Bevensen
More Information
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Responsible Party: Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT02895048    
Other Study ID Numbers: ID CP OPT2009-007
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases