Optimizer System With ODOCOR II CCM™ Leads

NCT04755569 | Unknown

• 1 other identifier: Impulse Dynamics
• Study Type: observational
• Target: 200
• Locations: 3 countries
• Sites: 40

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 IPG.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  12 months

• 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.

  12 month

Secondary Outcomes (2)

• Secondary Safety endpoint

  12 month

• Secondary Efficacy endpoint

  12 month

Other Outcomes (1)

• Additional Endpoints

  at implant

Interventions

ODOCOR II CCM LEADS DEVICE

ODOCOR II CCM LEADS Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Impulse Dynamics: lead

Study Sites (40)

Klinik am Plattenwald

Heilbronn, Baden-Wurttemberg, 74177, Germany

WITHDRAWN

St. Anna Krankenhaus

Sulzbach-Rosenberg, Bavaria, 92237, Germany

RECRUITING

St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, Hesse, 65189, Germany

WITHDRAWN

Elbe Klinikum Stade

Stade, Lower Saxony, 21682, Germany

WITHDRAWN

Augusta-Kranken-Anstalt Bochum-Mitte

Bochum, North Rhine-Westphalia, 44791, Germany

RECRUITING

Krankenhaus Marie-Hilf Stadtlohn

Stadtlohn, North Rhine-Westphalia, 48703, Germany

RECRUITING

Herzzentrum Dresden

Dresden, Saxony, 01307, Germany

WITHDRAWN

Klinikum Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

WITHDRAWN

DRK Kliniken Berlin Koepenick

Berlin, 12559, Germany

RECRUITING

Charité Berlin Campus Virchow

Berlin, 13353, Germany

RECRUITING

Evangelisches Klinikum Bethel

Bielefeld, 33617, Germany

RECRUITING

Regiomed Kliniken-Coburg

Coburg, Germany

RECRUITING

SRH Krankenhaus Waltershausen-Friedrichroda

Friedrichroda, 99894, Germany

RECRUITING

Marienhospital

Gelsenkirchen, 45886, Germany

RECRUITING

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

RECRUITING

Schoen Klinik Hamburg Eilbek

Hamburg, 22081, Germany

RECRUITING

Evangelisches Krankenhaus Herne

Herne, 44623, Germany

RECRUITING

St. Marien-Hospital Klinikum Luenen

Lünen, D-44534, Germany

NOT YET RECRUITING

Universitaetsklinikum UMM

Mannheim, Germany

RECRUITING

Niels-Stensen-Kliniken Marienhospital Osnabrück GmbH

Osnabrück, 49074, Germany

WITHDRAWN

Azienda Ospedaliera Dei Colli-Monaldi

Naples, Campania, 80131, Italy

RECRUITING

Ospedale "Sacra Famiglia" - Fatebenefratelli dell'

Erba, Lombardo Veneta, 22036, Italy

RECRUITING

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

Acquaviva delle Fonti, Italy

RECRUITING

Ospedale C. e G. "Mazzoni"

Ascoli Piceno, 63100, Italy

RECRUITING

Ospedale San Paolo, UOC Cardiologia ed UTIC

Bari, 70123, Italy

RECRUITING

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

Bari, Italy

RECRUITING

IRCCS Policlinico Sant'Orsola-Malpighi

Bologna, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, Italy

RECRUITING

Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari

Castrovillari, Italy

RECRUITING

ASL TO 4 - Presidio Ospedaliero Riunito sede di Cirie

Cirié, Italy

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Azienda Ospedaliera Universitaria Maggiore della Carita

Novara, 28100, Italy

RECRUITING

Gruppo Synergo - Casa Di Cura Pierangeli

Pescara, 65124, Italy

RECRUITING

Presidio Ospedaliero Sant'Andrea

Vercelli, 13100, Italy

RECRUITING

Ospedale San Bortolo di Vicenza - Azienda UlSS 8 Berica

Vicenza, 36100, Italy

RECRUITING

Complejo Hospitario Torrecardenas

Almería, 04009, Spain

RECRUITING

Hospital Virgen de las Nieves

Granada, 18014, Spain

RECRUITING

Hospital 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Puerta de Hierro

Madrid, 28222, Spain

RECRUITING

Hospital Clinico U. de Santiago

Santiago de Compostela, 15706, Spain

RECRUITING

Study Officials

• Stefano DeVivo, MD

  Monaldi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Stagg

CONTACT

+01 845 558 9391; astagg@impulsedynamics.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 16, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (20); IT (15); ES (5)