NCT04755569

Optimizer System With ODOCOR II CCM™ Leads

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Impulse Dynamics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	ODOCOR II CCM LEADS	ODOCOR II CCM LEADS Implantation

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2021-02-16
• Last updated: 2023-08-02

Locations

40 sites across 3 countries: Germany, Italy, Spain