NCT02895048

Effects of CCM-therapy in Patients With Heart Failure

Clinical Effects of Cardiac Contractility Modulation (CCM) With the OPTIMIZER III System in Subjects With Heart Failure Caused by Left Ventricular Dysfunction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 184 (actual)
• Sponsor: Stiftung Institut fuer Herzinfarktforschung · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-08-01
• Completion: 2013-11-01
• First posted: 2016-09-09
• Last updated: 2016-09-09

Locations

1 site across 1 country: Germany