Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-28 @ 12:47 AM
Study NCT ID:
NCT04694859
Status:
UNKNOWN
Last Update Posted:
2021-01-05
First Post:
2020-12-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-31', 'studyFirstSubmitDate': '2020-12-31', 'studyFirstSubmitQcDate': '2020-12-31', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '1-year', 'description': 'All cause mortality'}], 'secondaryOutcomes': [{'measure': 'Stroke', 'timeFrame': '1-year', 'description': 'Ischemic or hemorrhagic cerebrovascular accident'}, {'measure': 'Bleeding', 'timeFrame': '1-year', 'description': 'Major bleeding'}, {'measure': 'Myocardial ischemia', 'timeFrame': '1-year', 'description': 'Acute myocardial infarction or recurrent angina'}, {'measure': 'Arrhythmia', 'timeFrame': '1-year', 'description': 'Arrhythmias requiring permanent pacemaker implantation'}, {'measure': 'Vascular complications', 'timeFrame': '1-year', 'description': 'Procedure related vascular complications'}, {'measure': 'Acute kidney injury', 'timeFrame': '1-year', 'description': 'Procedure related renal dysfunction'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['aortic stenosis'], 'conditions': ['Aortic Stenosis Symptomatic', 'Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '8459080', 'type': 'BACKGROUND', 'citation': 'Lindroos M, Kupari M, Heikkila J, Tilvis R. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample. J Am Coll Cardiol. 1993 Apr;21(5):1220-5. doi: 10.1016/0735-1097(93)90249-z.'}, {'pmid': '22922698', 'type': 'BACKGROUND', 'citation': 'Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available.'}, {'pmid': '22443479', 'type': 'BACKGROUND', 'citation': 'Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.'}, {'pmid': '23026738', 'type': 'BACKGROUND', 'citation': 'Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium (VARC)-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi: 10.1093/ejcts/ezs533. Epub 2012 Oct 1.'}, {'pmid': '31510787', 'type': 'BACKGROUND', 'citation': 'Iung B, Delgado V, Rosenhek R, Price S, Prendergast B, Wendler O, De Bonis M, Tribouilloy C, Evangelista A, Bogachev-Prokophiev A, Apor A, Ince H, Laroche C, Popescu BA, Pierard L, Haude M, Hindricks G, Ruschitzka F, Windecker S, Bax JJ, Maggioni A, Vahanian A; EORP VHD II Investigators. Contemporary Presentation and Management of Valvular Heart Disease: The EURObservational Research Programme Valvular Heart Disease II Survey. Circulation. 2019 Oct;140(14):1156-1169. doi: 10.1161/CIRCULATIONAHA.119.041080. Epub 2019 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'RO-TAVI is a national prospective, observational, multi-center registry registry of patients with aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI) to assess patient care and outcomes.', 'detailedDescription': 'Background: Since the establishment of transcatheter aortic valve implantation (TAVI) in Romania in 2015 there has been a growing number of interventions being performed by an increasing number of hospitals throughout the country. In 2018, there were more than 250 implants, which are expected to grow in the following years by about 30% on an annual basis.\n\nObjective: This is a national quality assurance initiative to improve patient care and outcomes. It further serves as a database for the assessment of the safety and efficacy of TAVI and its financial implications (e.g. reimbursement).\n\nDesign: National, prospective, observational, multi-center registry. All centers performing TAVI in Romania; minimum cases per center for inclusion: 20 cases/year-to-date Population: All patients undergoing TAVI in Romania at any of the participating centers with a CE-marked valve of any manufacturer given that they provide written informed consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years old diagnosed with symptomatic severe aortic valve stenosis undergoing TAVI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe symptomatic aortic valve stenosis\n* high risk or patients deemed amenable for TAVI by a multidisciplinary team\n* signed informed consent to participate in the study\n\nExclusion Criteria:\n\n* inadequate annulus size (\\<18 mm, \\>29 mm)\n* left ventricle thrombus\n* active endocarditis\n* high risk of coronary ostium obstruction\n* plaques with mobile thrombi in the ascending aorta, or arch\n* hemodynamic instability\n* estimated life expectancy \\<1 year\n* comorbidity suggesting lack of improvement of quality of life\n* other situations adjudicated by the local HeartTeam'}, 'identificationModule': {'nctId': 'NCT04694859', 'acronym': 'RO-TAVI', 'briefTitle': 'Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI', 'organization': {'class': 'OTHER', 'fullName': 'Romanian Society of Cardiology'}, 'officialTitle': 'Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI', 'orgStudyIdInfo': {'id': 'RO-TAVI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Symptomatic Severe Aortic Valve Stenosis', 'description': 'Patients \\>18 years old with symptomatic severe aortic valve stenosis.', 'interventionNames': ['Device: Transcatheter Aortic Valve Implantation']}], 'interventions': [{'name': 'Transcatheter Aortic Valve Implantation', 'type': 'DEVICE', 'description': 'Transfemoral or transapical Transcatheter Aortic Valve Implantation', 'armGroupLabels': ['Symptomatic Severe Aortic Valve Stenosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '030423', 'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Catalina A Parasca, MD', 'role': 'CONTACT', 'email': 'catalina.parasca@gmail.com', 'phone': '+40773842692'}, {'name': 'Vlad A Iliescu, MD PhD', 'role': 'CONTACT', 'email': 'vladanton.iliescu@gmail.com', 'phone': '+40722244055'}, {'name': 'Dan Deleanu, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ovidiu Chioncel, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stefan Mot, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cristian Udroiu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Horatiu Moldovan, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Grigore Tinica, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Horatiu Suciu, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Catalina A. Parasca, MD', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'centralContacts': [{'name': 'Catalina A Parasca, MD', 'role': 'CONTACT', 'email': 'catalina.parasca@gmail.com', 'phone': '+40773842692'}, {'name': 'Bogdan A Popescu, MD PhD', 'role': 'CONTACT', 'email': 'bogdan.a.popescu@gmail.com', 'phone': '+40722611305'}], 'overallOfficials': [{'name': 'Vlad A Iliescu, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania'}, {'name': 'Bogdan A Popescu, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania'}, {'name': 'Dragos Vinereanu, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Romanian Society of Cardiology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}