Status:
UNKNOWN
Optimizer System With ODOCOR II CCM™ Leads
Lead Sponsor:
Impulse Dynamics
Conditions:
Evaluate the Safety and Useability of the ODOCOR II Intra-cardiac Lead
Eligibility:
All Genders
18+ years
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 IP...
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 Clas...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04755569
Start Date
March 1 2021
End Date
December 31 2025
Last Update
August 2 2023
Active Locations (40)
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1
Klinik am Plattenwald
Heilbronn, Baden-Wurttemberg, Germany, 74177
2
St. Anna Krankenhaus
Sulzbach-Rosenberg, Bavaria, Germany, 92237
3
St. Josefs-Hospital Wiesbaden GmbH
Wiesbaden, Hesse, Germany, 65189
4
Elbe Klinikum Stade
Stade, Lower Saxony, Germany, 21682