Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT04755569
Status:
RECRUITING
Last Update Posted:
2023-08-02
First Post:
2021-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizer System With ODOCOR II CCM™ Leads
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2021-02-11', 'studyFirstSubmitQcDate': '2021-02-11', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Additional Endpoints', 'timeFrame': 'at implant', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Primary Safety endpoint', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Primary Efficacy endpoint', 'timeFrame': '12 month', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Secondary Safety endpoint', 'timeFrame': '12 month', 'description': 'The secondary safety endpoint is an assessment of the lead-related "observations" occurring during the 12-month study.'}, {'measure': 'Secondary Efficacy endpoint', 'timeFrame': '12 month', 'description': 'Change in QOL, as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ), from baseline to 12 months following index implantation procedure.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Evaluate the Safety and Useability of the ODOCOR II Intra-cardiac Lead']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Design A prospective, multi-center, single arm open label study, 12-month study of 400 ODOCOR II CCM™ leads in 200 subjects .\n\nMethod 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.\n\nEndpoints Primary Safety endpoint\n\nThe 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.\n\nSecondary Safety endpoint\n\nThe secondary safety endpoint is an assessment of the lead-related "observations" occurring during the 12-month study.\n\nPrimary 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.\n\nSecondary 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.\n\nAdditional 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.\n\nPatients, sites Four hundred (400) ODOCOR II CCM leads will be implanted in 200 eligible subjects from up to 40 sites in Europe.\n\nDuration The total investigation is expected to last approximately 3 years , including enrollment and follow-up periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The total investigation is expected to last approximately 3 years , including enrollment and follow-up periods.\n\nFour hundred (400) ODOCOR II CCM leads will be implanted in 200 eligible subjects from up to 40 sites in Europe', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient signed and dated informed consent form\n2. Male or non-pregnant female, aged 18 or older\n3. Left ventricular ejection fraction of 25-45% (inclusive)\n4. Diagnosed with NYHA Class III or IV heart failure\n5. Stated willingness to comply with all study procedures and availability for the duration of the study\n6. Medically stable and with no significant mental illness in the judgement of the principal investigator\n\nExclusion Criteria:\n\n1. Infiltrative or inflammatory cardiomyopathy (e.g. amyloid, hemochromatosis, myocarditis, hypertrophic cardiomyopathy, Fabry's disease, cardiac tumor)\n2. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 3 months of the baseline testing visit.\n3. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days before the baseline testing visit, including continuous IV inotrope therapy\n4. Myocardial infarction within 3 months of the baseline testing visit.\n5. Undergone a CABG procedure within 3 months90 days or a PTCA procedure within 30 days of the baseline testing visit.\n6. Undergone a cardiac ablation procedure within 90 days prior to consent.\n7. Prior heart transplant or ventricular assist device\n8. Mechanical tricuspid valve\n9. Receiving cardiac resynchronization therapy (CRT) or indicated for Class I CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy\n10. Currently on dialysis\n11. Currently undergoing active chemotherapeutic and/or radiation treatment for cancer\n12. Participating in another cardiac investigational device study at the same time\n13. 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.\n14. Expected lifespan of less than 12 months from time the baseline testing visit.\n15. Resting heart rate \\>110 bpm at the time of the baseline testing visit\n16. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements\n17. Subjects currently admitted to the hospital with a primary diagnosis of heart failure\n\n \\-"}, 'identificationModule': {'nctId': 'NCT04755569', 'briefTitle': 'Optimizer System With ODOCOR II CCM™ Leads', 'organization': {'class': 'INDUSTRY', 'fullName': 'Impulse Dynamics'}, 'officialTitle': 'Clinical Investigation of the ODOCOR II CCM™ Leads in Patients With Optimizer System Implant', 'orgStudyIdInfo': {'id': 'Impulse Dynamics'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ODOCOR II CCM LEADS', 'type': 'DEVICE', 'description': 'ODOCOR II CCM LEADS Implantation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '74177', 'city': 'Heilbronn', 'state': 'Baden-Wurttemberg', 'status': 'WITHDRAWN', 'country': 'Germany', 'facility': 'Klinik am Plattenwald', 'geoPoint': {'lat': 49.13995, 'lon': 9.22054}}, {'zip': '92237', 'city': 'Sulzbach-Rosenberg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Flamur Kryezi, Dr.', 'role': 'CONTACT', 'email': 'f.kryezi@kh-as.de', 'phone': '+49 170 1039794'}, {'name': 'Flamur Kryezi, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Anna Krankenhaus', 'geoPoint': {'lat': 49.50126, 'lon': 11.74598}}, {'zip': '65189', 'city': 'Wiesbaden', 'state': 'Hesse', 'status': 'WITHDRAWN', 'country': 'Germany', 'facility': 'St. Josefs-Hospital Wiesbaden GmbH', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': '21682', 'city': 'Stade', 'state': 'Lower Saxony', 'status': 'WITHDRAWN', 'country': 'Germany', 'facility': 'Elbe Klinikum Stade', 'geoPoint': {'lat': 53.59407, 'lon': 9.47302}}, {'zip': '44791', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Magnus W. Prull, Dr.', 'role': 'CONTACT', 'email': 'm.prull@augusta-bochum.de', 'phone': '0049234 5172351'}, {'name': 'Vanessa Traebing', 'role': 'CONTACT', 'email': 'v.traebing@augusta-bochum.de', 'phone': '0049234 5172235'}], 'facility': 'Augusta-Kranken-Anstalt Bochum-Mitte', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '48703', 'city': 'Stadtlohn', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alessandro Cuneo, Dr.', 'role': 'CONTACT', 'email': 'alessandro.cuneo@kwml.de', 'phone': '0049 25639126961'}, {'name': 'Britta Fitz', 'role': 'CONTACT', 'email': 'britta.fitz@kwml.de', 'phone': '0049 25639126373'}, {'name': 'Alessandro Cuneo, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krankenhaus Marie-Hilf Stadtlohn', 'geoPoint': {'lat': 51.99399, 'lon': 6.91918}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'status': 'WITHDRAWN', 'country': 'Germany', 'facility': 'Herzzentrum Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '39120', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'status': 'WITHDRAWN', 'country': 'Germany', 'facility': 'Klinikum Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '12559', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sebastian Spencker, Dr.', 'role': 'CONTACT', 'email': 's.spencker@drk-kliniken-berlin.de', 'phone': '0049 3030353318'}, {'name': 'Silke Helms', 'role': 'CONTACT', 'email': 's.helms@drk-kliniken-berlin.de', 'phone': '0049 3030353777'}, {'name': 'Sebastian Spencker, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'DRK Kliniken Berlin Koepenick', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Florian Blaschke, Dr.', 'role': 'CONTACT', 'email': 'florian.blaschke@charite.de', 'phone': '+49 30 450 653635'}, {'name': 'Svenja Broschag', 'role': 'CONTACT', 'email': 'svenja.broschag@charite.de', 'phone': '+49 30 450 653762'}, {'name': 'Florian Blaschke, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Phillip Lacour, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Charité Berlin Campus Virchow', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '33617', 'city': 'Bielefeld', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Carsten W. Israel', 'role': 'CONTACT', 'email': 'carsten.israel@evkb.de', 'phone': '+49 52177277525'}, {'name': 'Christina Schaefer', 'role': 'CONTACT', 'phone': '+49 521 772 77640'}, {'name': 'Carsten W. Israel', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tobias Feldmann', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Evangelisches Klinikum Bethel', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'city': 'Coburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Petra Suenkel', 'role': 'CONTACT', 'email': 'petra.suenkel@regiomed-kliniken.de', 'phone': '+49 9561 2233248'}, {'name': 'Sonia Busch, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Regiomed Kliniken-Coburg', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'zip': '99894', 'city': 'Friedrichroda', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joachim Schuemmelfeder', 'role': 'CONTACT', 'email': 'joachim.schuemmelfeder@kwf.srh.de', 'phone': '+49 3623 3500'}, {'name': 'Andrea Litzkow', 'role': 'CONTACT', 'email': 'andrea.Litzkow@srh.de'}, {'name': 'Joachim Schuemmelfeder', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SRH Krankenhaus Waltershausen-Friedrichroda', 'geoPoint': {'lat': 50.85754, 'lon': 10.56507}}, {'zip': '45886', 'city': 'Gelsenkirchen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Axel Kloppe, PD Dr. med.', 'role': 'CONTACT', 'email': 'a.kloppe@marienhospital.eu', 'phone': '+49 172 28 26 868'}], 'facility': 'Marienhospital', 'geoPoint': {'lat': 51.50508, 'lon': 7.09654}}, {'zip': '20099', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Lukas Kaiser, Dr.', 'role': 'CONTACT', 'email': 'k.lukas@asklepios.com', 'phone': '0049 4018188555406'}, {'name': 'Claudia Kalkowski', 'role': 'CONTACT', 'email': 'c.kalkowski@asklepios.com', 'phone': '0049 401818852070'}, {'name': 'Lukas Kaiser, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asklepios Klinik St. Georg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22081', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Frank Hennersdorf', 'role': 'CONTACT', 'email': 'fhennersdorf@schoen-klinik.de', 'phone': '+49 40 20921201'}, {'name': 'Frank Hennersdorf', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Schoen Klinik Hamburg Eilbek', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '44623', 'city': 'Herne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ali Halboos', 'role': 'CONTACT', 'email': 'a.halboos@evk-herne.de'}, {'name': 'Ali Halboos', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Evangelisches Krankenhaus Herne', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'zip': 'D-44534', 'city': 'Lünen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Perings, Dr.', 'role': 'CONTACT', 'email': 'Perings.Christian@klinikum-luenen.de'}], 'facility': 'St. Marien-Hospital Klinikum Luenen', 'geoPoint': {'lat': 51.61634, 'lon': 7.52872}}, {'city': 'Mannheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Juergen Kuschyk, Prof. Dr.', 'role': 'CONTACT', 'email': 'juergen.kuschyk@umm.de', 'phone': '+49 1713453211'}, {'name': 'Brigitte Kircher', 'role': 'CONTACT', 'email': 'brigitte.kircher@umm.de', 'phone': '+49 6213831993'}, {'name': 'Juergen Kuschyk', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Boris Rudic', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitaetsklinikum UMM', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '49074', 'city': 'Osnabrück', 'status': 'WITHDRAWN', 'country': 'Germany', 'facility': 'Niels-Stensen-Kliniken Marienhospital Osnabrück GmbH', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'zip': '80131', 'city': 'Naples', 'state': 'Campania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': "Antonio D'Onofrio, Dr.", 'role': 'CONTACT', 'email': 'donofrioant1@gmail.com'}, {'name': "Antonio D'Onofrio, Dr.", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Dei Colli-Monaldi', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '22036', 'city': 'Erba', 'state': 'Lombardo Veneta', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Sagone, Dr.', 'role': 'CONTACT', 'email': 'asagone@fatebenefratelli.eu'}], 'facility': 'Ospedale "Sacra Famiglia" - Fatebenefratelli dell\'', 'geoPoint': {'lat': 45.8088, 'lon': 9.22609}}, {'city': 'Acquaviva delle Fonti', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Caccavo, Dr.', 'role': 'CONTACT', 'email': 'v.caccavo73@gmail.com'}, {'name': 'Vincenzo Caccavo, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nicola Vitulano, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ente Ecclesiastico Ospedale Generale Regionale "F.Miulli" Cardiologia e U.T.I.C.', 'geoPoint': {'lat': 40.89704, 'lon': 16.8433}}, {'zip': '63100', 'city': 'Ascoli Piceno', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Procolo Marchese, Dr.', 'role': 'CONTACT', 'email': 'procolo.marchese@gmail.com'}, {'name': 'Francesca Gennaro, Dr.', 'role': 'CONTACT', 'email': 'francescagennaro@hotmail.com'}, {'name': 'Procolo Marchese, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale C. e G. "Mazzoni"', 'geoPoint': {'lat': 42.85351, 'lon': 13.57395}}, {'zip': '70123', 'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luigi Mancini, Dr.', 'role': 'CONTACT', 'email': 'drluigimancini@gmail.com'}, {'name': 'Gianluca Robles, Dr.', 'role': 'CONTACT', 'email': 'gianlucarobles24@gmail.com'}, {'name': 'Luigi Mancini, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale San Paolo, UOC Cardiologia ed UTIC', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': "Carlo D'Agostino, Dr", 'role': 'CONTACT', 'email': 'carlo.dagostino@policlinico.ba.it'}, {'name': 'Rossella Troccoli, Dr', 'role': 'CONTACT', 'email': 'rossella.troccoli@gmail.com'}, {'name': "Carlo D'Agostino, Dr", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Universitaria Consorziale - Policlinico di Bari U.O.C Cardiologia Ospedaliera', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Igor Diemberger, Dr.', 'role': 'CONTACT', 'email': 'igor.diemberger@unibo.it'}, {'name': 'Igor Diemberger', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "IRCCS Policlinico Sant'Orsola-Malpighi", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Cagliari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Nissardi, Dr.', 'role': 'CONTACT', 'email': 'vnissardi@aoucagliari.it'}, {'name': 'Vincenzo Nissardi, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero-Universitaria di Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Castrovillari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Silvana De Bonis, Dr.', 'role': 'CONTACT', 'email': 'silvanadebonis68@gmail.com'}, {'name': 'Silvana De Bonis, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antonio Mazziotti, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari', 'geoPoint': {'lat': 39.81632, 'lon': 16.20183}}, {'city': 'Cirié', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gaetano Senatore, Dr.', 'role': 'CONTACT', 'email': 'gsenatore@aslto4.piemonte.it', 'phone': '003901192171'}, {'name': 'Gaetano Senatore, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASL TO 4 - 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