Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT06267612
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Corheart 6 LVAS Long-term Follow-up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2024-02-02', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device implantaion success rate at 24 months post-implantation', 'timeFrame': 'Up to 24 months post-implantation', 'description': 'Device implantation success is defined as:\n\n* A. Electively transplanted or explanted prior to 24 months or\n* B. Alive at 24 months, and\n* I. Have not experienced a stroke with a modified Rankin Score \\> 3, and\n* II. Have not received a device replacement or exchange due to a device malfunction, and\n* III. Have not received an urgent transplant due to a device malfunction.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)', 'timeFrame': 'Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation', 'description': 'Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.'}, {'measure': 'Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire', 'timeFrame': 'Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation', 'description': 'The scores from the 5 dimensions are summed for the total score, with higher scores indicating more problems and a worse quality of life.'}, {'measure': 'Functional status as measured by the Six Minute Walk Test (6MWT)', 'timeFrame': 'Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation', 'description': 'The more meters a patient can walk over baseline indicates improvement in functional status.'}, {'measure': 'Functional status as measured by the New York Heart Association (NYHA) Classification', 'timeFrame': 'Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation', 'description': 'NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status.'}, {'measure': 'Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score', 'timeFrame': 'Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation', 'description': 'Scores range from 0 to 42. Higher scores indicate more severe disability'}, {'measure': 'Stroke severity as assessed by the modified Rankin Scale (mRS) score', 'timeFrame': 'Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation', 'description': 'Scores range from 0 to 6. Higher scores indicate more severe disability'}, {'measure': 'Adverse events', 'timeFrame': 'As they occur, from baseline to 24 months post-implantaion', 'description': 'Frequency and incidence of all anticipated adverse events'}, {'measure': 'Device-related re-operations', 'timeFrame': 'As they occur, from baseline to 24 months post-implantaion', 'description': 'Frequency and incidence of all device-related re-operations'}, {'measure': 'Device-related re-hospitalizations', 'timeFrame': 'As they occur, from initial hospital discharge to 24 months post-implantation', 'description': 'Frequency and incidence of all device-related re-hospitalizations'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 60 months post-implantation', 'description': 'Overall survival at 60 months post-implantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure.\n\nThe study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years.\n* 2\\. The patient or legal representative is willing to participate in the study and offers informed consent.\n* 3\\. Body surface area (BSA) ≥ 1.0 m\\^2.\n* 4\\. Females of childbearing age must agree to use adequate contraception.\n* 5\\. Patients with NYHA Class IV heart failure symptoms who have failed to be reversed by standardized treatment with oral anti-heart failure drugs.\n* 6\\. Left Ventricular Ejection Fraction (LVEF) ≤ 35%, and at least one of the following conditions occurs:\n* a. Fail to be reversed by or be weaned from intra-aortic balloon pump (IABP), extracorporeal membrane oxygenator (ECMO), or other short-term mechanical circulatory support.\n* b. Rely on continuous intravenous administration of one or more vasoactive or inotropic drugs.\n* c. Meeting the diagnostic criteria of cardiogenic shock: blood pressure \\< 90/60mmHg, cardiac index \\< 2.0 L/min/m\\^2 (optional), and pulmonary capillary wedge pressure \\> 18mmHg (optional).\n\nExclusion Criteria:\n\n* 1\\. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive hypertrophic cardiomyopathy, or pericardial disease.\n* 2\\. Presence of an active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.\n* 3\\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.\n* 4\\. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy the investigator will require based on the patient's health status.\n* 5\\. Patients require bi-ventricular assist device support.\n* 6\\. Pregnancy.\n* 7\\. Presence of moderate to severe aortic insufficiency or a history of the mechanical aortic valve that will not be converted to a bioprosthesis or oversewn at the time of implantation.\n* 8\\. History of any organ transplantation.\n* 9\\. Presence of uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation.\n* 10\\. TBIL (total bilirubin) \\> 3.0 mg/dL within 48 hours prior to implantation.\n* 11\\. Serum creatinine (SCr) \\> 3.0 mg/dL within 48 hours prior to implantation or may require dialysis.\n* 12\\. Presence of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension.\n* 13\\. Presence of pulmonary embolism within 3 weeks prior to implantation.\n* 14\\. Pulmonary artery systolic pressure exceeds 60mmHg, combined with at least one of the following 2 parameters demonstrating that pulmonary vascular resistance did not respond to drug therapy:\n* a. Pulmonary vascular resistance greater than 8 wood units.\n* b. The transpulmonary differential pressure exceeds 20mmHg.\n* 15\\. Established and untreated abdominal or thoracic aortic aneurysm \\> 5cm in diameter.\n* 16\\. Presence of severe peripheral vascular disease with resting pain or extremity ulceration.\n* 17\\. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management, or brain death from various causes.\n* 18\\. History of documented disabling stroke within 90 days prior to implantation, a history of cerebrovascular disease, or the presence of uncorrected severe bilateral carotid artery stenosis.\n* 19\\. History of acute myocardial infarction within 60 days prior to implantation, judged by the investigator to have a risk of myocardial rupture or other surgical high-risk difficult-to-control bleeding, etc.\n* 20\\. Expected lifetime of less than 1 year due to malignant tumor or other disease.\n* 21\\. Participation in any other clinical study that may influence the results of this study.\n* 22\\. Other circumstances that are unforeseen and determined by the researcher to be unsuitable."}, 'identificationModule': {'nctId': 'NCT06267612', 'briefTitle': 'Corheart 6 LVAS Long-term Follow-up Study', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Long-term Follow-up Study of Corheart 6 Left Ventricular Assist System as Treatment of Patients With Advanced Heart Failure', 'orgStudyIdInfo': {'id': 'KY20231109-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Corheart 6 LVAS', 'description': 'Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced heart failure.', 'interventionNames': ['Device: Corheart 6 Left Ventricular Assist System']}], 'interventions': [{'name': 'Corheart 6 Left Ventricular Assist System', 'type': 'DEVICE', 'description': 'Implantation of left ventricular assist device for hemodynamic support', 'armGroupLabels': ['Corheart 6 LVAS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Zhibing Qiu', 'role': 'CONTACT', 'email': 'qiuzhibing2009@163.com'}], 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Zhibing Qiu', 'role': 'CONTACT', 'email': 'qiuzhibing2009@163.com', 'phone': '025-52271064'}], 'overallOfficials': [{'name': 'Zhibing Qiu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhibing Qiu', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}