Effects of CCM-therapy in Patients With Heart Failure

Completed

• Conditions: Heart Failure

• Registration Number: NCT02895048
• Lead Sponsor: Stiftung Institut fuer Herzinfarktforschung

Brief Summary

The effects of Cardiac Contractility Modulation (CCM) treatment are observed in patients with 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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-07
• Primary Completion: 2013-08
• Study Completion: 2013-11
• Status Verified: 2016-06
• Study First Submitted QC: 2016-09-05
• Last Update Submitted: 2016-09-05
• Study First Posted: 2016-09-09
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause and cardiac mortality	24 Months

Secondary Outcome Measures

Name	Time	Method
the rate of all-cause and cardiac-related hospitalizations	24 Months

Trial Locations

Locations (1)

CCB; 🇩🇪 Frankfurt/Main, Hesse, Germany