Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-26 @ 4:18 PM
Study NCT ID:
NCT04810195
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2021-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 554}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2021-03-07', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE', 'timeFrame': '30 days', 'description': 'any of\n\n* Postoperative aortic insuffiency moderate or higher (in hospital echo, site reported)\n* Postoperative new permanent pacemaker (in hospital)\n* 30 days mortality\n* 30 days stroke\n* Acute Kidney Injury (AKIN grade 3) (in hospital)'}], 'secondaryOutcomes': [{'measure': 'Rate of Postoperative aortic insufficiency more than mild by transthoracic echo', 'timeFrame': 'Within 7 days of procedure', 'description': 'Core-lab analysis of the postoperative transthoracic echo for aortic insufficiency: percentage of patients with more than mild insufficiency'}, {'measure': 'Rate of Postoperative aortic insufficiency more than mild by aortography', 'timeFrame': 'Same day as procedure', 'description': 'Core-lab analysis of the aortogram in the end of the procedure for quantification of aortic insufficiency (videodensitometry): rate of patients with more than mild insuffiency'}, {'measure': 'Postoperative aortic valve gradients', 'timeFrame': 'Within 7 days of procedure', 'description': 'Aortic prosthesis mean gradient (mmHg) on postoperative transthoracic echocardiogram'}, {'measure': 'Rate of major acute procedural complications', 'timeFrame': 'Same day as procedure', 'description': 'Intraprocedural complications such as valve embolization, need for second valve, anular rupture'}, {'measure': 'Procedural contrast use', 'timeFrame': 'Same day as procedure', 'description': 'The average amount of contrast in ml per procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['TAVR'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals. The data is gathered from routine healthcare and there are no study-mandated additional procedures. The main endpoint is a combined efficiency and safety endpoint after 30 days. Imaging data (echocardiography, computed tomography and aortography) will be analysed centrally by a core lab.', 'detailedDescription': 'Background and rationale The Boston Scientific Acurate neo2 TAVI prosthesis was launched commercially in Europe in September 2020 as a successor to the original Acurate neo prosthesis. Modifications include an added sealing skirt. The original Acurate neo failed to reach non-inferiority to other TAVI prostheses in two randomized trials. There is a need to gather initial safety and efficacy data from this next generation prosthesis, as there is no larger dataset presented after the CE-mark study of the Acurate neo2.\n\nProject objectives To gather initial safety and efficacy data in the initial up to 500 consecutive patients treated with the Acurate neo2 in various European sites.\n\nKarolinska will be the coordinating center for data collection.\n\nMethods Data will be collected in an anonymous form and sent to Karolinska for compilation and statistics. Data collection will continue until 500 patients are reached (April, 2021).\n\nStatistics Standard descriptive statistics will be used for the main results. For the comparison to SCOPE data (with the original Acurate neo prosthesis) on postoperative aortic insufficiency, standard statistical methods will used (Fishers exact test for categorical variables, and t-test for continuous measurements such as amount of regurgitation by videodensitometry).\n\nCore lab studies The core lab analyses will be performed at CORRIB in Galway (Prof. Serruys et al).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The first 500 consecutive patients treated with the Acurate neo2 from up to 15 European sites which have started using the Acurate neo2.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* that a Acurate neo2 prosthesis has been inserted into the sheath (i.e. a procedure has been started).\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04810195', 'briefTitle': 'Early neo2 Registry of the Acurate neo2 TAVI Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Early neo2 Registry of the Acurate neo2 TAVI Prosthesis', 'orgStudyIdInfo': {'id': 'HKN AR01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Boston Scientific Acurate neo2 TAVR device', 'type': 'DEVICE', 'description': 'The newest generation of the Acurate neo2 TAVR device, launched in Europe in 2020.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff Klinik', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Andreas Rück, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andreas Rück', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andreas Rück', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}