Evaluate the Safety and Useability of the ODOCOR II Intra-cardiac Lead Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 - |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Charité Berlin Campus Virchow | Berlin | |
| Germany | DRK Kliniken Berlin Koepenick | Berlin | |
| Germany | Evangelisches Klinikum Bethel | Bielefeld | |
| Germany | Augusta-Kranken-Anstalt Bochum-Mitte | Bochum | North Rhine-Westphalia |
| Germany | Regiomed Kliniken-Coburg | Coburg | |
| Germany | Herzzentrum Dresden | Dresden | Saxony |
| Germany | SRH Krankenhaus Waltershausen-Friedrichroda | Friedrichroda | |
| Germany | Marienhospital | Gelsenkirchen | |
| Germany | Asklepios Klinik St. Georg | Hamburg | |
| Germany | Schoen Klinik Hamburg Eilbek | Hamburg | |
| Germany | Klinik am Plattenwald | Heilbronn | Baden Wuerttemberg |
| Germany | Evangelisches Krankenhaus Herne | Herne | |
| Germany | St. Marien-Hospital Klinikum Luenen | Lünen | |
| Germany | Klinikum Magdeburg | Magdeburg | Saxony-Anhalt |
| Germany | Universitaetsklinikum UMM | Mannheim | |
| Germany | Niels-Stensen-Kliniken Marienhospital Osnabrück GmbH | Osnabrück | |
| Germany | Elbe Klinikum Stade | Stade | Lower Saxony |
| Germany | Krankenhaus Marie-Hilf Stadtlohn | Stadtlohn | North Rhine Westphalia |
| Germany | St. Anna Krankenhaus | Sulzbach-Rosenberg | Bavaria |
| Germany | St. Josefs-Hospital Wiesbaden GmbH | Wiesbaden | Hessen |
| 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 | Azienda Ospedaliero Universitaria Consorziale - Policlinico di Bari U.O.C Cardiologia Ospedaliera | Bari | |
| Italy | Ospedale San Paolo, UOC Cardiologia ed UTIC | 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 | Ciriè | |
| Italy | Ospedale "Sacra Famiglia" - Fatebenefratelli dell' | Erba | Lombardo Veneta |
| Italy | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | |
| Italy | Azienda Ospedaliera Dei Colli-Monaldi | Naples | Campania |
| 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 | |
| Spain | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Impulse Dynamics |
Germany, Italy, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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. | at implant | |
| Primary | 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 | 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 | Secondary Safety endpoint | The secondary safety endpoint is an assessment of the lead-related "observations" occurring during the 12-month study. | 12 month | |
| Secondary | 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. | 12 month |