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Cardiac Contractility Modulation (CCM) Therapy in Subjects With Medically Refractory Heart Failure

NCT02857309 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-09-02

No results posted yet for this study

Summary

The study is designed to substantiate the efficacy of Cardiac Contractility Modulation (CCM) in the heart failure population with ejection fraction ranging between 25 and 45%. The study is designed in an adaptive manner to ensure proper statistical significance and power of the primary efficacy evaluation.

Conditions

Interventions

DEVICE

OPTIMIZER

The OPTIMIZER System delivers non-excitatory cardiac contractility modulation (CCM) signals to the heart that are intended to influence myocardial properties in patients with chronic heart failure. The system has no pacemaker or implantable cardioverter-defibrillator (ICD) functions.

DRUG

Optimal medical therapy

OMT using standard heart failure (HF) drugs

Sponsors & Collaborators

  • Impulse Dynamics

    lead INDUSTRY

Principal Investigators

  • Gerhard Hindricks, Prof. · Herzzentrum Leipzig GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2018-02-15
Completion
2018-02-15

Countries

  • Austria
  • Germany
  • Poland
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02857309 on ClinicalTrials.gov