Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2021-03-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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ODOCOR II CCM LEADS
ODOCOR II CCM LEADS Implantation
Eligibility Criteria
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Inclusion Criteria
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
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
\-
18 Years
ALL
No
Sponsors
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Impulse Dynamics
INDUSTRY
Responsible Party
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Principal Investigators
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Stefano DeVivo, MD
Role: PRINCIPAL_INVESTIGATOR
Monaldi Hospital
Locations
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Klinik am Plattenwald
Heilbronn, Baden-Wurttemberg, Germany
St. Anna Krankenhaus
Sulzbach-Rosenberg, Bavaria, Germany
St. Josefs-Hospital Wiesbaden GmbH
Wiesbaden, Hesse, Germany
Elbe Klinikum Stade
Stade, Lower Saxony, Germany
Augusta-Kranken-Anstalt Bochum-Mitte
Bochum, North Rhine-Westphalia, Germany
Krankenhaus Marie-Hilf Stadtlohn
Stadtlohn, North Rhine-Westphalia, Germany
Herzzentrum Dresden
Dresden, Saxony, Germany
Klinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany
DRK Kliniken Berlin Koepenick
Berlin, , Germany
Charité Berlin Campus Virchow
Berlin, , Germany
Evangelisches Klinikum Bethel
Bielefeld, , Germany
Regiomed Kliniken-Coburg
Coburg, , Germany
SRH Krankenhaus Waltershausen-Friedrichroda
Friedrichroda, , Germany
Marienhospital
Gelsenkirchen, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Schoen Klinik Hamburg Eilbek
Hamburg, , Germany
Evangelisches Krankenhaus Herne
Herne, , Germany
St. Marien-Hospital Klinikum Luenen
Lünen, , Germany
Universitaetsklinikum UMM
Mannheim, , Germany
Niels-Stensen-Kliniken Marienhospital Osnabrück GmbH
Osnabrück, , Germany
Azienda Ospedaliera Dei Colli-Monaldi
Naples, Campania, Italy
Ospedale "Sacra Famiglia" - Fatebenefratelli dell'
Erba, Lombardo Veneta, Italy
Ente Ecclesiastico Ospedale Generale Regionale "F.Miulli" Cardiologia e U.T.I.C.
Acquaviva delle Fonti, , Italy
Ospedale C. e G. "Mazzoni"
Ascoli Piceno, , Italy
Ospedale San Paolo, UOC Cardiologia ed UTIC
Bari, , Italy
Azienda Ospedaliero Universitaria Consorziale - Policlinico di Bari U.O.C Cardiologia Ospedaliera
Bari, , Italy
IRCCS Policlinico Sant'Orsola-Malpighi
Bologna, , Italy
Azienda Ospedaliero-Universitaria di Cagliari
Cagliari, , Italy
Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari
Castrovillari, , Italy
ASL TO 4 - Presidio Ospedaliero Riunito sede di Cirie
Cirié, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Universitaria Maggiore della Carita
Novara, , Italy
Gruppo Synergo - Casa Di Cura Pierangeli
Pescara, , Italy
Presidio Ospedaliero Sant'Andrea
Vercelli, , Italy
Ospedale San Bortolo di Vicenza - Azienda UlSS 8 Berica
Vicenza, , Italy
Complejo Hospitario Torrecardenas
Almería, , Spain
Hospital Virgen de las Nieves
Granada, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Puerta de Hierro
Madrid, , Spain
Hospital Clinico U. de Santiago
Santiago de Compostela, , Spain
Countries
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Central Contacts
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Facility Contacts
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Christina Schaefer
Role: backup
Javier de Juan Baguda, Dr.
Role: primary
Javier Garcia Seara, Dr.
Role: primary
Other Identifiers
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Impulse Dynamics
Identifier Type: -
Identifier Source: org_study_id
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