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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    200
  • sponsor
    Impulse Dynamics
Updated on 13 October 2022

Summary

The objective of the ODOCOR II CCM lead study is to evaluate the safety and useability of the ODOCOR II intra-cardiac lead specifically intended to deliver CCM as an accessory lead to the Optimizer IPG.

Description

Design A prospective, multi-center, single arm open label study, 12-month study of 400 ODOCOR II CCM™ leads in 200 subjects .

Method Subjects shall be enrolled that have been diagnosed with NYHA Class III-IV heart failure and left ventricular ejection fraction (25-45% inclusive). Eligible subjects will receive the Optimizer IPG device implant with 2 ODOCOR II CCM leads. Subjects will return for follow-up visits at 2-weeks, 6 months and 12 months following the device implant.

Endpoints Primary Safety endpoint

The primary safety endpoint is the incidence of lead-related complication free rate at 12 months post-index implantation procedure compared to the incidence previously described in the literature for pacing therapy leads.

Secondary Safety endpoint

The secondary safety endpoint is an assessment of the lead-related "observations" occurring during the 12-month study.

Primary Efficacy endpoint The total amount of CCM delivered to the cardiac tissue of the right ventricle (measured by CCM percentage) will be measured over a period of 12 months.

Secondary Efficacy endpoint Change in QOL, as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ), from baseline to 12 months following index implantation procedure.

Additional Endpoints Handling characteristics of the lead will be evaluated by the implanting physician. Ease of insertion, lead visibility on x-ray, and the ability to visualize the helix deployment will be assessed via a questionnaire administered at the completion of an implant procedure.

Patients, sites Four hundred (400) ODOCOR II CCM leads will be implanted in 200 eligible subjects from up to 40 sites in Europe.

Duration The total investigation is expected to last approximately 3 years , including enrollment and follow-up periods.

Details
Condition Evaluate the Safety and Useability of the ODOCOR II Intra-cardiac Lead
Treatment ODOCOR II CCM LEADS
Clinical Study IdentifierNCT04755569
SponsorImpulse Dynamics
Last Modified on13 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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