Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-28 @ 5:33 AM
Study NCT ID:
NCT04755569
Status:
RECRUITING
Last Update Posted:
2023-08-02
First Post:
2021-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizer System With ODOCOR II CCM™ Leads
Sponsor:
Impulse Dynamics
Organization:
Study Overview
Official Title:
Clinical Investigation of the ODOCOR II CCM™ Leads in Patients With Optimizer System Implant
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: