Optimizer System With ODOCOR II CCM™ Leads

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Evaluate the Safety and Useability of the ODOCOR II Intra-cardiac Lead

Intervention / Treatment
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* Device: ODOCOR II CCM LEADS


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ODOCOR II CCM LEADS|ODOCOR II CCM LEADS Implantation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| 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. | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety endpoint | The secondary safety endpoint is an assessment of the lead-related observations occurring during the 12-month study. | 12 month | 
| 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. | 12 month |