Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT04782232
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2021-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D000080039', 'term': 'Univentricular Heart'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of mortality', 'timeFrame': '30 days', 'description': 'Short-term mortality'}, {'measure': 'Rate of major bleeding', 'timeFrame': '30 days', 'description': 'Short-term rate of major bleeding'}, {'measure': 'Rate of thrombosis', 'timeFrame': '30 days', 'description': 'Short-term rate of thrombosis'}, {'measure': 'Survival to heart transplantation', 'timeFrame': 'up to 12 months', 'description': 'Long-term survival to heart transplantation'}], 'secondaryOutcomes': [{'measure': 'Rate of adverse events', 'timeFrame': 'up to 12 months', 'description': 'Safety of the device'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EXCOR Ventricular Assist Device', 'EXCOR Venous Cannula', 'Failing Fontan'], 'conditions': ['Heart Failure', 'Univentricular Heart', 'Ventricular Dysfunction', 'Heart Diseases', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '36368697', 'type': 'DERIVED', 'citation': 'Dal Sasso E, Schondorf T, Schluter KJ, Miera O, De Rita F, Menon AK; European EXCOR(R) Pediatric Investigator Group (EEPIG). A Novel Strategy for the Mechanical Subpulmonary Support in Failing Fontan Patients. Thorac Cardiovasc Surg. 2022 Dec;70(S 03):e34-e41. doi: 10.1055/s-0042-1757916. Epub 2022 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term.', 'detailedDescription': 'The registry study has an observational, prospective, international, multi-center, non-randomized design.\n\nThe registry is planned for 42 months (3.5 years), with an enrollment period of 28 months, the follow-up of up to 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Twenty patients with failing/absence of the right heart. The indications on RVAD and BVAD use of the EXCOR VAD apply.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient or his/her parent/guardian or legally authorized representative has given the consent by means of a written, signed and dated informed consent form,\n* The indications on RVAD and BVAD use of the EXCOR VAD apply,\n* Patient shall be on transplant list or at least eligible for HTx,\n* BSA (body surface area) greater than or equal to 1.2 m².\n\nExclusion Criteria:\n\n* Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent,\n* The contraindications of EXCOR VAD apply.'}, 'identificationModule': {'nctId': 'NCT04782232', 'acronym': 'RegiVe', 'briefTitle': 'Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart', 'organization': {'class': 'INDUSTRY', 'fullName': 'Berlin Heart GmbH'}, 'officialTitle': 'Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart', 'orgStudyIdInfo': {'id': 'E-20-325'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with failing/absence of the right heart', 'description': 'Patients with acute or chronic, conservatively uncontrollable heart failure of varying pathogenesis, graded as stage III or IV according to NYHA, with an anticipated need for short-term to long-term right ventricular or biventricular support.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention due to observational design', 'armGroupLabels': ['Patients with failing/absence of the right heart']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'LMU Klinikum', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Thomas Schöndorf, Dr. Dr. PD', 'role': 'CONTACT', 'email': 'clinical.science@berlinheart.de', 'phone': '+49 30 81872600'}, {'name': 'Eleonora Dal Sasso, Dr.', 'role': 'CONTACT', 'email': 'clinical.science@berlinheart.de', 'phone': '+49 30 81872600'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Berlin Heart GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}