UnknownNot Applicable

Optimizer System With ODOCOR II CCM™ Leads

Germany, Italy, Spain200 participantsStarted 2021-03-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Safety endpoint

Timeframe: 12 months

Primary Efficacy endpoint

Timeframe: 12 month

Trial details

NCT IDNCT04755569

SponsorImpulse Dynamics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-31

Contact for this trial

Angela Stagg

+01 845 558 9391 astagg@impulsedynamics.com

View on ClinicalTrials.gov More Evaluate the Safety and Useability of the ODOCOR II Intra-cardiac Lead trials