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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02895048

Acronym

CCM-HF

Enrollment

184

Registered

2016-09-09

Start date

2011-09-30

Completion date

2013-11-30

Last updated

2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
All-cause and cardiac mortality	24 Months

Secondary

Measure	Time frame
the rate of all-cause and cardiac-related hospitalizations	24 Months

Countries

Germany

Outcome results