Phase
Condition
N/ATreatment
ODOCOR II CCM LEADS
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 theduration of the study
- 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
Study Description
Connect with a study center
Klinik am Plattenwald
Heilbronn, Baden Wuerttemberg 74177
GermanySite Not Available
St. Anna Krankenhaus
Sulzbach-Rosenberg, Bavaria 92237
GermanyActive - Recruiting
St. Josefs-Hospital Wiesbaden GmbH
Wiesbaden, Hessen 65189
GermanySite Not Available
Elbe Klinikum Stade
Stade, Lower Saxony 21682
GermanySite Not Available
Krankenhaus Marie-Hilf Stadtlohn
Stadtlohn, North Rhine Westphalia 48703
GermanyActive - Recruiting
Augusta-Kranken-Anstalt Bochum-Mitte
Bochum, North Rhine-Westphalia 44791
GermanyActive - Recruiting
Herzzentrum Dresden
Dresden, Saxony 01307
GermanySite Not Available
Klinikum Magdeburg
Magdeburg, Saxony-Anhalt 39120
GermanySite Not Available
Charité Berlin Campus Virchow
Berlin, 13353
GermanyActive - Recruiting
DRK Kliniken Berlin Koepenick
Berlin, 12559
GermanyActive - Recruiting
Evangelisches Klinikum Bethel
Bielefeld, 33617
GermanyActive - Recruiting
Regiomed Kliniken-Coburg
Coburg,
GermanyActive - Recruiting
SRH Krankenhaus Waltershausen-Friedrichroda
Friedrichroda, 99894
GermanyActive - Recruiting
Marienhospital
Gelsenkirchen, 45886
GermanyActive - Recruiting
Asklepios Klinik St. Georg
Hamburg, 20099
GermanyActive - Recruiting
Schoen Klinik Hamburg Eilbek
Hamburg, 22081
GermanyActive - Recruiting
Evangelisches Krankenhaus Herne
Herne, 44623
GermanyActive - Recruiting
St. Marien-Hospital Klinikum Luenen
Lünen, D-44534
GermanySite Not Available
Universitaetsklinikum UMM
Mannheim,
GermanyActive - Recruiting
Niels-Stensen-Kliniken Marienhospital Osnabrück GmbH
Osnabrück, 49074
GermanySite Not Available
Azienda Ospedaliera Dei Colli-Monaldi
Naples, Campania 80131
ItalyActive - Recruiting
Ospedale "Sacra Famiglia" - Fatebenefratelli dell'
Erba, Lombardo Veneta 22036
ItalyActive - Recruiting
Ente Ecclesiastico Ospedale Generale Regionale "F.Miulli" Cardiologia e U.T.I.C.
Acquaviva Delle Fonti,
ItalyActive - Recruiting
Ospedale C. e G. "Mazzoni"
Ascoli Piceno, 63100
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Consorziale - Policlinico di Bari U.O.C Cardiologia Ospedaliera
Bari,
ItalyActive - Recruiting
Ospedale San Paolo, UOC Cardiologia ed UTIC
Bari, 70123
ItalyActive - Recruiting
IRCCS Policlinico Sant'Orsola-Malpighi
Bologna,
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria di Cagliari
Cagliari,
ItalyActive - Recruiting
Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari
Castrovillari,
ItalyActive - Recruiting
ASL TO 4 - Presidio Ospedaliero Riunito sede di Cirie
Ciriè,
ItalyActive - Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Maggiore della Carita
Novara, 28100
ItalyActive - Recruiting
Gruppo Synergo - Casa Di Cura Pierangeli
Pescara, 65124
ItalyActive - Recruiting
Presidio Ospedaliero Sant'Andrea
Vercelli, 13100
ItalyActive - Recruiting
Ospedale San Bortolo di Vicenza - Azienda UlSS 8 Berica
Vicenza, 36100
ItalyActive - Recruiting
Complejo Hospitario Torrecardenas
Almería, 04009
SpainActive - Recruiting
Hospital Virgen de las Nieves
Granada, 18014
SpainActive - Recruiting
Hospital 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Puerta de Hierro
Madrid, 28222
SpainActive - Recruiting
Hospital Clinico U. de Santiago
Santiago De Compostela, 15706
SpainActive - Recruiting
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