Optimizer System With ODOCOR II CCM™ Leads

August 1, 2023 updated by: Impulse Dynamics

Clinical Investigation of the ODOCOR II CCM™ Leads in Patients With Optimizer System Implant

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 12559
      • Berlin, Germany, 13353
        • Recruiting
        • Charité Berlin Campus Virchow
        • Contact:
        • Contact:
        • Principal Investigator:
          • Florian Blaschke, Dr.
        • Sub-Investigator:
          • Phillip Lacour, Dr.
      • Bielefeld, Germany, 33617
        • Recruiting
        • Evangelisches Klinikum Bethel
        • Contact:
        • Contact:
          • Christina Schaefer
          • Phone Number: +49 521 772 77640
        • Principal Investigator:
          • Carsten W. Israel
        • Sub-Investigator:
          • Tobias Feldmann
      • Coburg, Germany
        • Recruiting
        • Regiomed Kliniken-Coburg
        • Contact:
        • Principal Investigator:
          • Sonia Busch, PD Dr.
      • Friedrichroda, Germany, 99894
      • Gelsenkirchen, Germany, 45886
      • Hamburg, Germany, 20099
        • Recruiting
        • Asklepios Klinik St. Georg
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lukas Kaiser, Dr.
      • Hamburg, Germany, 22081
        • Recruiting
        • Schoen Klinik Hamburg Eilbek
        • Contact:
        • Principal Investigator:
          • Frank Hennersdorf
      • Herne, Germany, 44623
        • Recruiting
        • Evangelisches Krankenhaus Herne
        • Contact:
        • Principal Investigator:
          • Ali Halboos
      • Lünen, Germany, D-44534
      • Mannheim, Germany
        • Recruiting
        • Universitaetsklinikum UMM
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juergen Kuschyk
        • Sub-Investigator:
          • Boris Rudic
      • Osnabrück, Germany, 49074
        • Withdrawn
        • Niels-Stensen-Kliniken Marienhospital Osnabrück GmbH
    • Baden Wuerttemberg
      • Heilbronn, Baden Wuerttemberg, Germany, 74177
        • Withdrawn
        • Klinik am Plattenwald
    • Bavaria
      • Sulzbach-Rosenberg, Bavaria, Germany, 92237
        • Recruiting
        • St. Anna Krankenhaus
        • Contact:
        • Principal Investigator:
          • Flamur Kryezi, Dr.
    • Hessen
      • Wiesbaden, Hessen, Germany, 65189
        • Withdrawn
        • St. Josefs-Hospital Wiesbaden GmbH
    • Lower Saxony
      • Stade, Lower Saxony, Germany, 21682
        • Withdrawn
        • Elbe Klinikum Stade
    • North Rhine Westphalia
      • Stadtlohn, North Rhine Westphalia, Germany, 48703
        • Recruiting
        • Krankenhaus Marie-Hilf Stadtlohn
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alessandro Cuneo, Dr.
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44791
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Withdrawn
        • Herzzentrum Dresden
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Withdrawn
        • Klinikum Magdeburg
  • Italy
      • Acquaviva Delle Fonti, Italy
        • Recruiting
        • Ente Ecclesiastico Ospedale Generale Regionale "F.Miulli" Cardiologia e U.T.I.C.
        • Contact:
        • Principal Investigator:
          • Vincenzo Caccavo, Dr.
        • Sub-Investigator:
          • Nicola Vitulano, Dr.
      • Ascoli Piceno, Italy, 63100
      • Bari, Italy, 70123
      • Bari, Italy
      • Bologna, Italy
        • Recruiting
        • IRCCS Policlinico Sant'Orsola-Malpighi
        • Contact:
        • Principal Investigator:
          • Igor Diemberger
      • Cagliari, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Cagliari
        • Contact:
        • Principal Investigator:
          • Vincenzo Nissardi, Dr.
      • Castrovillari, Italy
        • Recruiting
        • Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari
        • Contact:
        • Principal Investigator:
          • Silvana De Bonis, Dr.
        • Sub-Investigator:
          • Antonio Mazziotti, Dr.
      • Ciriè, Italy
        • Recruiting
        • ASL TO 4 - Presidio Ospedaliero Riunito sede di Cirie
        • Contact:
        • Principal Investigator:
          • Gaetano Senatore, Dr.
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
        • Contact:
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliera Universitaria Maggiore della Carita
        • Contact:
        • Principal Investigator:
          • Giuseppe Patti
        • Sub-Investigator:
          • Gabriele Dell'Era
        • Sub-Investigator:
          • Camilla Marconetto
      • Pescara, Italy, 65124
        • Recruiting
        • Gruppo Synergo - Casa Di Cura Pierangeli
        • Contact:
        • Principal Investigator:
          • Stefano Guarracini, Dr.
      • Vercelli, Italy, 13100
        • Recruiting
        • Presidio Ospedaliero Sant'Andrea
        • Contact:
        • Principal Investigator:
          • Francesco Rametta
      • Vicenza, Italy, 36100
    • Campania
      • Naples, Campania, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Dei Colli-Monaldi
        • Contact:
        • Principal Investigator:
          • Antonio D'Onofrio, Dr.
    • Lombardo Veneta
      • Erba, Lombardo Veneta, Italy, 22036
  • Spain
      • Almería, Spain, 04009
        • Recruiting
        • Complejo Hospitario Torrecardenas
        • Contact:
        • Principal Investigator:
          • Jesus Aceituno Cubero, Dr.
      • Granada, Spain, 18014
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital 12 de Octubre
        • Contact:
        • Contact:
          • Javier de Juan Baguda, Dr.
        • Principal Investigator:
          • Javier de Juan Baguda, Dr.
      • Madrid, Spain, 28222
        • Recruiting
        • Hospital Puerta de Hierro
        • Contact:
        • Principal Investigator:
          • Ignacio Fernandez Lozano, Dr.
      • Santiago De Compostela, Spain, 15706
        • Recruiting
        • Hospital Clinico U. de Santiago
        • Contact:
          • Javier Garcia Seara, Dr.
        • Contact:
        • Principal Investigator:
          • Javier Garcia Seara, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The total investigation is expected to last approximately 3 years , including enrollment and follow-up periods.

Four hundred (400) ODOCOR II CCM leads will be implanted in 200 eligible subjects from up to 40 sites in Europe

Description

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 the duration of the study
  6. Medically stable and with no significant mental illness in the judgement of the principal investigator

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 repair or clip within 3 months of the baseline testing visit.
  3. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days before 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 days of 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 CRT implantation 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 site investigator, would interfere with adherence to study requirements

  17. Subjects currently admitted to the hospital with a primary diagnosis of heart failure

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety endpoint
Time Frame: 12 months
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.
12 months
Primary Efficacy endpoint
Time Frame: 12 month
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.
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Safety endpoint
Time Frame: 12 month
The secondary safety endpoint is an assessment of the lead-related "observations" occurring during the 12-month study.
12 month
Secondary Efficacy endpoint
Time Frame: 12 month
Change in QOL, as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ), from baseline to 12 months following index implantation procedure.
12 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional Endpoints
Time Frame: at implant
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.
at implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Impulse Dynamics

Investigators

  • Principal Investigator: Stefano DeVivo, MD, Monaldi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Impulse Dynamics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Evaluate the Safety and Useability of the ODOCOR II Intra-cardiac Lead

Clinical Trials on ODOCOR II CCM LEADS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe