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.
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.
Study Type
OBSERVATIONAL
Enrollment
200
ODOCOR II CCM LEADS Implantation
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.
Time frame: 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.
Time frame: 12 month
Secondary Safety endpoint
The secondary safety endpoint is an assessment of the lead-related "observations" occurring during the 12-month study.
Time frame: 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.
Time frame: 12 month
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Heilbronn, Baden-Wurttemberg, Germany
WITHDRAWNSt. Anna Krankenhaus
Sulzbach-Rosenberg, Bavaria, Germany
RECRUITINGSt. Josefs-Hospital Wiesbaden GmbH
Wiesbaden, Hesse, Germany
WITHDRAWNElbe Klinikum Stade
Stade, Lower Saxony, Germany
WITHDRAWNAugusta-Kranken-Anstalt Bochum-Mitte
Bochum, North Rhine-Westphalia, Germany
RECRUITINGKrankenhaus Marie-Hilf Stadtlohn
Stadtlohn, North Rhine-Westphalia, Germany
RECRUITINGHerzzentrum Dresden
Dresden, Saxony, Germany
WITHDRAWNKlinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany
WITHDRAWNDRK Kliniken Berlin Koepenick
Berlin, Germany
RECRUITINGCharité Berlin Campus Virchow
Berlin, Germany
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