Optimizer System With ODOCOR II CCM™ Leads

Last updated: August 1, 2023
Sponsor: Impulse Dynamics
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

ODOCOR II CCM LEADS

Clinical Study ID

NCT04755569
Impulse Dynamics
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient signed and dated informed consent form
  2. Male or non-pregnant female, aged 18 or older
  3. Left ventricular ejection fraction of 25-45% (inclusive)
  4. Diagnosed with NYHA Class III or IV heart failure
  5. Stated willingness to comply with all study procedures and availability for theduration of the study
  6. Medically stable and with no significant mental illness in the judgement of theprincipal investigator

Exclusion

Exclusion Criteria: 1. Infiltrative or inflammatory cardiomyopathy (e.g. amyloid, hemochromatosis,myocarditis, hypertrophic cardiomyopathy, Fabry's disease, cardiac tumor) 2. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repairor clip within 3 months of the baseline testing visit. 3. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 daysbefore the baseline testing visit, including continuous IV inotrope therapy 4. Myocardial infarction within 3 months of the baseline testing visit. 5. Undergone a CABG procedure within 3 months90 days or a PTCA procedure within 30 daysof the baseline testing visit. 6. Undergone a cardiac ablation procedure within 90 days prior to consent. 7. Prior heart transplant or ventricular assist device 8. Mechanical tricuspid valve 9. Receiving cardiac resynchronization therapy (CRT) or indicated for Class I CRTimplantation according to the ACCF/AHA/HRS guidelines for device-based therapy 10. Currently on dialysis 11. Currently undergoing active chemotherapeutic and/or radiation treatment for cancer 12. Participating in another cardiac investigational device study at the same time 13. 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. 14. Expected lifespan of less than 12 months from time the baseline testing visit. 15. Resting heart rate >110 bpm at the time of the baseline testing visit 16. Current drug or alcohol use or dependence that, in the opinion of the siteinvestigator, would interfere with adherence to study requirements 17. Subjects currently admitted to the hospital with a primary diagnosis of heart failure

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: ODOCOR II CCM LEADS
Phase:
Study Start date:
March 01, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Klinik am Plattenwald

    Heilbronn, Baden Wuerttemberg 74177
    Germany

    Site Not Available

  • St. Anna Krankenhaus

    Sulzbach-Rosenberg, Bavaria 92237
    Germany

    Active - Recruiting

  • St. Josefs-Hospital Wiesbaden GmbH

    Wiesbaden, Hessen 65189
    Germany

    Site Not Available

  • Elbe Klinikum Stade

    Stade, Lower Saxony 21682
    Germany

    Site Not Available

  • Krankenhaus Marie-Hilf Stadtlohn

    Stadtlohn, North Rhine Westphalia 48703
    Germany

    Active - Recruiting

  • Augusta-Kranken-Anstalt Bochum-Mitte

    Bochum, North Rhine-Westphalia 44791
    Germany

    Active - Recruiting

  • Herzzentrum Dresden

    Dresden, Saxony 01307
    Germany

    Site Not Available

  • Klinikum Magdeburg

    Magdeburg, Saxony-Anhalt 39120
    Germany

    Site Not Available

  • Charité Berlin Campus Virchow

    Berlin, 13353
    Germany

    Active - Recruiting

  • DRK Kliniken Berlin Koepenick

    Berlin, 12559
    Germany

    Active - Recruiting

  • Evangelisches Klinikum Bethel

    Bielefeld, 33617
    Germany

    Active - Recruiting

  • Regiomed Kliniken-Coburg

    Coburg,
    Germany

    Active - Recruiting

  • SRH Krankenhaus Waltershausen-Friedrichroda

    Friedrichroda, 99894
    Germany

    Active - Recruiting

  • Marienhospital

    Gelsenkirchen, 45886
    Germany

    Active - Recruiting

  • Asklepios Klinik St. Georg

    Hamburg, 20099
    Germany

    Active - Recruiting

  • Schoen Klinik Hamburg Eilbek

    Hamburg, 22081
    Germany

    Active - Recruiting

  • Evangelisches Krankenhaus Herne

    Herne, 44623
    Germany

    Active - Recruiting

  • St. Marien-Hospital Klinikum Luenen

    Lünen, D-44534
    Germany

    Site Not Available

  • Universitaetsklinikum UMM

    Mannheim,
    Germany

    Active - Recruiting

  • Niels-Stensen-Kliniken Marienhospital Osnabrück GmbH

    Osnabrück, 49074
    Germany

    Site Not Available

  • Azienda Ospedaliera Dei Colli-Monaldi

    Naples, Campania 80131
    Italy

    Active - Recruiting

  • Ospedale "Sacra Famiglia" - Fatebenefratelli dell'

    Erba, Lombardo Veneta 22036
    Italy

    Active - Recruiting

  • Ente Ecclesiastico Ospedale Generale Regionale "F.Miulli" Cardiologia e U.T.I.C.

    Acquaviva Delle Fonti,
    Italy

    Active - Recruiting

  • Ospedale C. e G. "Mazzoni"

    Ascoli Piceno, 63100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Consorziale - Policlinico di Bari U.O.C Cardiologia Ospedaliera

    Bari,
    Italy

    Active - Recruiting

  • Ospedale San Paolo, UOC Cardiologia ed UTIC

    Bari, 70123
    Italy

    Active - Recruiting

  • IRCCS Policlinico Sant'Orsola-Malpighi

    Bologna,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria di Cagliari

    Cagliari,
    Italy

    Active - Recruiting

  • Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari

    Castrovillari,
    Italy

    Active - Recruiting

  • ASL TO 4 - Presidio Ospedaliero Riunito sede di Cirie

    Ciriè,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Maggiore della Carita

    Novara, 28100
    Italy

    Active - Recruiting

  • Gruppo Synergo - Casa Di Cura Pierangeli

    Pescara, 65124
    Italy

    Active - Recruiting

  • Presidio Ospedaliero Sant'Andrea

    Vercelli, 13100
    Italy

    Active - Recruiting

  • Ospedale San Bortolo di Vicenza - Azienda UlSS 8 Berica

    Vicenza, 36100
    Italy

    Active - Recruiting

  • Complejo Hospitario Torrecardenas

    Almería, 04009
    Spain

    Active - Recruiting

  • Hospital Virgen de las Nieves

    Granada, 18014
    Spain

    Active - Recruiting

  • Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Puerta de Hierro

    Madrid, 28222
    Spain

    Active - Recruiting

  • Hospital Clinico U. de Santiago

    Santiago De Compostela, 15706
    Spain

    Active - Recruiting

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