Effects of CCM-therapy in Patients With Heart Failure

Heart Failure Clinical Trial

— CCM-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895048
• Other study ID #: ID CP OPT2009-007
• Status: Completed
• Phase: N/A
• First received: October 7, 2011
• Last updated: September 5, 2016
• Start date: September 2011
• Est. completion date: November 2013

Study information

• Verified date: June 2016
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The effects of Cardiac Contractility Modulation (CCM) treatment are observed in patients with heart failure.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: November 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (treatment group):

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

Exclusion Criteria (treatment group):

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Germany	CCB	Frankfurt/Main	Hesse

Sponsors (2)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung	Impulse Dynamics

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause and cardiac mortality		24 Months	Yes
Secondary	the rate of all-cause and cardiac-related hospitalizations		24 Months	Yes