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Evaluating the safety and usability of the ODOCOR II intra-cardiac lead

Clinical Investigation of the ODOCOR II CCM™ Leads in Patients With Optimizer System Implant

Observational Impulse Dynamics · NCT04755569

This study is testing a new heart device called the ODOCOR II lead to see if it is safe and helpful for people with severe heart failure.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorImpulse Dynamics Industry-sponsored
Drugs / interventionsradiation
Locations40 sites (Heilbronn, Baden Wuerttemberg and 39 other locations)
Trial IDNCT04755569 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety and usability of the ODOCOR II intra-cardiac lead, which is designed to deliver Cardiac Contractility Modulation (CCM) therapy. It will involve a prospective, multi-center, single-arm approach with 200 subjects diagnosed with NYHA Class III-IV heart failure and a left ventricular ejection fraction between 25-45%. Participants will receive the Optimizer IPG device implant along with two ODOCOR II leads and will be monitored over a 12-month period for lead-related complications and quality of life changes. Follow-up visits will occur at 2 weeks, 6 months, and 12 months post-implantation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with NYHA Class III or IV heart failure and a left ventricular ejection fraction of 25-45%.

Not a fit: Patients with specific cardiomyopathies, recent myocardial infarction, or those requiring significant inotropic support may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment options for patients with advanced heart failure by providing a new method of cardiac therapy.

How similar studies have performed: While this approach is novel, similar studies evaluating cardiac leads have shown promising results in improving patient outcomes.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patient signed and dated informed consent form
2. Male or non-pregnant female, aged 18 or older
3. Left ventricular ejection fraction of 25-45% (inclusive)
4. Diagnosed with NYHA Class III or IV heart failure
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. Medically stable and with no significant mental illness in the judgement of the principal investigator

Exclusion Criteria:

1. Infiltrative or inflammatory cardiomyopathy (e.g. amyloid, hemochromatosis, myocarditis, hypertrophic cardiomyopathy, Fabry's disease, cardiac tumor)
2. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 3 months of the baseline testing visit.
3. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days before the baseline testing visit, including continuous IV inotrope therapy
4. Myocardial infarction within 3 months of the baseline testing visit.
5. Undergone a CABG procedure within 3 months90 days or a PTCA procedure within 30 days of the baseline testing visit.
6. Undergone a cardiac ablation procedure within 90 days prior to consent.
7. Prior heart transplant or ventricular assist device
8. Mechanical tricuspid valve
9. Receiving cardiac resynchronization therapy (CRT) or indicated for Class I CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy
10. Currently on dialysis
11. Currently undergoing active chemotherapeutic and/or radiation treatment for cancer
12. Participating in another cardiac investigational device study at the same time
13. Patient is in a vulnerable population (such as significant mental disability, prisoner) that in the judgement of the PI impedes ability to provide informed content.
14. Expected lifespan of less than 12 months from time the baseline testing visit.
15. Resting heart rate \>110 bpm at the time of the baseline testing visit
16. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
17. Subjects currently admitted to the hospital with a primary diagnosis of heart failure

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Where this trial is running

Heilbronn, Baden Wuerttemberg and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Evaluate the Safety and Useability of the ODOCOR II Intra-cardiac Lead
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.