Clinical Investigation of the ODOCOR II CCM™ Leads in Patients With Optimizer System Implant
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- STATUS
- Recruiting
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- End date
- Dec 31, 2024
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- participants needed
- 200
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- sponsor
- Impulse Dynamics
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 Identifier | NCT04755569 |
| Sponsor | Impulse Dynamics |
| Last Modified on | 13 October 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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