Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT02755220
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2016-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cingularbio® Heart Valve Clincial Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-26', 'studyFirstSubmitDate': '2016-04-24', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'device related adverse valve events', 'timeFrame': '12 month', 'description': 'device related events including Thromboembolism, Valve thrombosis,Major hemorrhage, Major paravalvular leak'}], 'secondaryOutcomes': [{'measure': 'rate of procedural success', 'timeFrame': 'post-operative', 'description': 'device implant success'}, {'measure': 'the difference between baseline and 1 year in Effective orifice area (EOA)', 'timeFrame': '1year', 'description': 'the difference between baseline and 1 year in Effective orifice area (EOA) in echocardiographic hemodynamic'}, {'measure': 'the difference between baseline and 1 year in pressure gradient (PG)', 'timeFrame': '1year', 'description': 'the difference between baseline and 1 year in pressure gradient (PG) in echocardiographic hemodynamic'}, {'measure': 'the difference between baseline and 1 year in Peak aortic valve velocity', 'timeFrame': '1year', 'description': 'the difference between baseline and 1 year in Peak aortic valve velocity in echocardiographic hemodynamic'}, {'measure': 'improvement in NYHA functional class', 'timeFrame': '1year', 'description': 'the NYHA score between baseline and 1 year'}, {'measure': 'mortality', 'timeFrame': '1 year', 'description': 'the mortality rate at 1 year'}, {'measure': 'structural valve deterioration', 'timeFrame': '1 year', 'description': 'the SVD rate at 1 year'}, {'measure': 'reoperation', 'timeFrame': '1 year', 'description': 'the reoperation rate at 1 year'}, {'measure': 'valve-related adverse events', 'timeFrame': '1 year', 'description': 'all valve related AEs (not primary endpoint events) at 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diseases of Mitral and Aortic Valves']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement in Chinese population', 'detailedDescription': 'single arm, 12 month follow up, mutile center, to assess the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The inclusion criteria were as follows: 1) patient who had heart valve disease requiring a surgical replacement as indicated in the preoperative evaluation; 2) patient aged between 60-85 years; 3) patient whose preoperative heart function less than NYHA functional class IV; 4) patient who signed the informed consent before surgery; 5) patient who agrees to finish the follow-up. The exclusion criteria were as follows: 1) patient with prior valve replacement; 2) patient who requires concomitant tricuspid or pulmonary valve replacement; 3) patient who requires concomitant coronary artery bypass graft surgery; 4) patient with active infective endocarditis or drug abuse; 5) patient whose life time expectancy less than 12 months; 6) patient who was unable to follow anticoagulation treatment.'}, 'identificationModule': {'nctId': 'NCT02755220', 'briefTitle': 'Cingularbio® Heart Valve Clincial Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Cingularbio Co. Ltd'}, 'officialTitle': 'A Prospective, Mutli-center, Open Lable, Single Arm Study to Evaluate the Safety and Effectiveness of Cingularbio® Heart Valve in Aortic/Mitral Valve Replacement Patients', 'orgStudyIdInfo': {'id': 'XZBM-2015-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cingularbio® Heart valve', 'description': 'the patients will replaced by artificial heart valve', 'interventionNames': ['Device: Cingularbio® Aortic valve replacement']}], 'interventions': [{'name': 'Cingularbio® Aortic valve replacement', 'type': 'DEVICE', 'description': 'the patients will be replaced by Cingularbio heart valve', 'armGroupLabels': ['Cingularbio® Heart valve']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'country': 'Belgium', 'facility': 'Cardiale Heelkunde', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Katowice', 'country': 'Poland', 'facility': 'Klinika Kardiochirurgii', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Klinika Kardiochirurgii', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Klinika Kardiochirurgii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'chunsheng wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the publication will be started after study close out'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Cingularbio Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}