Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT02909556
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2016-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2016-09-16', 'studyFirstSubmitQcDate': '2016-09-16', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of all-cause mortality at 30 days follow-up', 'timeFrame': '30 days post-implant'}], 'secondaryOutcomes': [{'measure': 'Rate of clinical events as defined per VARC guidelines', 'timeFrame': '7 days, 30 days, 12 months post-implant', 'description': 'Clinical events:\n\n* Mortality\n* Stroke\n* Myocardial infarction\n* Bleeding complication\n* Acute kidney injury\n* Vascular complication\n* Conduction disturbances and arrhythmia\n* Other TAVI-related complications'}, {'measure': 'Procedural success', 'timeFrame': 'Day of implant', 'description': '2\\. Procedural success defined as absence of complications arising during implantation of the prosthetic valve such as: inability to properly seat the valve in the annulus; need for more than one aortic bioprosthesis (valve in valve); or if a surgical aortic valve replacement is required to correct a severe aortic regurgitation or procedure complication'}, {'measure': 'Device success', 'timeFrame': 'Day of implant', 'description': '3\\. Device success defined as:\n\n* Absence of intra-procedure mortality AND,\n* Correct positioning of a single prosthetic heart valve into the proper anatomical location AND,\n* Intended performance of the prosthetic heart valve (EOAi \\>0.85 cm2/m2 and mean aortic valve gradient \\<20mmHg without moderate or severe AR)'}, {'measure': 'VARC Composite Safety at 30 days', 'timeFrame': '30 days'}, {'measure': 'Clinical improvement from baseline as per NYHA Functional Classification', 'timeFrame': '7 days, 30 days, 12 months post-implant'}, {'measure': 'Improvement from baseline in hemodynamic function: effective orifice area, mean transprosthetic gradient', 'timeFrame': '7 days, 30 days, 12 months'}, {'measure': 'Total aortic regurgitation', 'timeFrame': '7 days, 30 days, 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcatheter Aortic Valve Replacement', 'TAVI', 'Transcatheter Aortic Valve Implant', 'Transfemoral access'], 'conditions': ['Aortic Stenosis']}, 'descriptionModule': {'briefSummary': 'Clinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.', 'detailedDescription': 'Single arm, prospecitve, multicenter, non-randomized and open trial. The purpose of this trial is to collect and safety and performance data concerning the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System\n\nThe ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis.\n\nThe primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery.\n\nThe secondary objective is to evaluate adverse events and study device performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient 75 years of age and older\n2. Severe aortic stenosis defined as:\n\n * Mean aortic gradient \\> 40 mmHg or\n * Peak jet velocity \\> 4.0 m/s or\n * Aortic valve area of \\< 1.0 cm2\n3. High risk candidate for conventional AVR defined as:\n\n * Logistic EuroSCORE 1 ≥ 20% or\n * STS Score ≥ 8% or\n * Heart team (cardiologist and cardiac surgeon) consensus that patient is not a surgical candidate for conventional AVR due to significant co-morbid conditions unrelated to aortic stenosis\n4. NYHA Functional Class \\> II\n5. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT\n6. Patient willing to participate in the study and provides signed informed consent\n\nExclusion Criteria:\n\n1. Congenital aortic stenosis or unicuspid or bicuspid aortic valve\n2. Non-stenotic Aortic Insufficiency\n3. Severe eccentricity of calcification\n4. Severe mitral regurgitation (\\>2+)\n5. Presence of mitral bioprosthesis\n6. Presence of previously implanted aortic bioprosthesis\n7. Presence of prosthetic ring\n8. Anatomy NOT appropriate for transfemoral implant due to the size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries\n9. Thoracic (TAA) or abdominal (AAA) aortic aneurysm\n10. Presence of endovascular stent graft for treatment of TAA or AAA\n11. Trans-oesophageal echocardiogram (TEE) is contraindicated\n12. Evidence of intra-cardiac mass, thrombus or vegetation\n13. Severe ventricular dysfunction with ejection fraction \\< 20%\n14. Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure\n15. Acute Myocardial Infarction within 1 month prior to implant procedure\n16. Previous TIA or stroke within 3 months prior to implant procedure\n17. Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure\n18. Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit\n19. Severe coagulation conditions\n20. Refusal of blood transfusions\n21. Systolic pressure \\<80mmHg, cardiogenic shock, need for inotropic support or IABP\n22. Hypertrophic cardiomyopathy with or without obstruction\n23. Active bacterial endocarditis or other active infections\n24. Hepatic failure (\\> Child B)\n25. Chronic renal dysfunction with serum creatinine \\> 2.5 mg/dL or renal dialysis\n26. Refusal of surgery\n27. Severe COPD requiring home oxygen\n28. Neurological disease severely affecting ambulation or daily functioning, or dementia\n29. Life expectancy \\< 12 months due to non-cardiac co-morbid conditions\n30. Inability to tolerate anticoagulation therapy\n31. Contraindication to contrast media or allergy to nickel\n32. Currently participating in an investigational drug or another device study\n33. Non-valvular aortic stenosis\n34. Non-calcific acquired aortic stenosis'}, 'identificationModule': {'nctId': 'NCT02909556', 'briefTitle': 'ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis', 'orgStudyIdInfo': {'id': '2016-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACURATE neo AS', 'interventionNames': ['Device: Transcatheter aortic valve replacement']}], 'interventions': [{'name': 'Transcatheter aortic valve replacement', 'type': 'DEVICE', 'otherNames': ['ACURATE neo™ AS Aortic Bioprosthesis (Commercial name: ACURATE neo2™ Aortic Valve)', 'ACURATE neo™ AS TF Transfemoral Delivery System (Commercial name: ACURATE neo2™ Transfemoral Delivery System)'], 'description': 'Transcatheter aortic valve replacement via transfemoral access', 'armGroupLabels': ['ACURATE neo AS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik Forschungsgesellschaft mbH', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'city': 'Dortmund', 'country': 'Germany', 'facility': 'Johannes Hospital', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Herzchirurgie', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitäres Herzzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig GmbH', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '80636', 'city': 'München', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Universitätsklinik Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '6000', 'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Luzerner Kantonsspital', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'overallOfficials': [{'name': 'Helge Möllmann, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Innere Medizin - St.-Johannes-Hospital - Dortmund, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Symetis SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}