Effects of CCM-therapy in Patients With Heart Failure

NCT02895048 | Completed

• 1 other identifier: ID CP OPT2009-007
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• All-cause and cardiac mortality

  24 Months

Secondary Outcomes (1)

• the rate of all-cause and cardiac-related hospitalizations

  24 Months

Study Arms (2)

Chronic heart failure

CCM treatment

Subjects with heart failure receiving OPTIMIZER system implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None
• 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
• 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

Sponsors & Collaborators

• Stiftung Institut fuer Herzinfarktforschung: lead
• Impulse Dynamics: collaborator

Study Sites (1)

CCB

Frankfurt am Main, Hesse, 29549, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Andrew Remppis, Professor

  Bad Bevensen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: September 9, 2016
• Study Start: September 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 9, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)