UnknownNot Applicable

Optimizer System With ODOCOR II CCM™ Leads

Germany200 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 range18 Years

SexALL

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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.
✕. 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

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