Symptomatic Aortic Stenosis Clinical Trial
— WINTAVIOfficial title:
Women's INternational Transcatheter Aortic Valve Implantation Registry
NCT number | NCT01819181 |
Other study ID # | GCO 14-1774 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | April 26, 2018 |
Verified date | May 2018 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The study will evaluate all female patients with severe aortic stenosis undergoing transcatheter valve implantation with commercially available valves and delivery systems.
Status | Completed |
Enrollment | 1019 |
Est. completion date | April 26, 2018 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Severe AS determined by echocardiogram and Doppler, defined as: mean gradient >40 mmHg or peak jet velocity >4.0 m/s and an aortic valve area =0.8 cm2 or aortic valve area index =0.5 cm2/m2 2. Symptomatic AS demonstrated by angina, congestive heart failure, NYHA functional class = II, or syncope 3. Logistic EuroSCORE suitable for TAVI 4. Patient must have other conditions (such as severe airways disease, porcelain aorta, previous thoracic radiotherapy, Childs Pugh class B and C liver disease) such that the multi-disciplinary team (interventional cardiologists, cardiothoracic surgeons and cardiac anaesthesiologists) agree that co-morbidities render SAVR of high or prohibitive risk. 5. Patient has been informed of the nature of the registry and has provided full written informed consent according to hospital practise Exclusion Criteria: 1. Patient is not an eligible candidate for TAVI 2. Untreated clinically significant (> 70% obstruction) coronary artery disease in the proximal segments of main branches suitable for revascularization 3. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation 4. Hemodynamic instability (e.g. requiring inotropic support) 5. Active endocarditis or sepsis within 6-months prior to the study procedure 6. Use of investigational device without CE mark |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Privé Parly 2 | Le Chesnay | |
Italy | Azienda Ospedaliero - Ferrarotto Alessi | Catania | |
Italy | Instituto Clinico Humanitas | Milan | |
Italy | San Raffaele Hospital | Milan | |
Italy | Department cardiovascular Sciences Policlinico Umberto I | Rome | |
Netherlands | Radboud University Nijmegen Medical Center | Nijmegen | |
Netherlands | Erasmus Medical Center Rotterdam | Rotterdam | |
Spain | Hospital Universitario Miguel Servet | Zaragoza. | |
United Kingdom | Imperial College | London | |
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | Society for Cardiovascular Angiography and Interventions |
United States, France, Italy, Netherlands, Spain, United Kingdom,
Buchanan GL, Chieffo A, Montorfano M, Maisano F, Latib A, Godino C, Cioni M, Gullace MA, Franco A, Gerli C, Alfieri O, Colombo A. The role of sex on VARC outcomes following transcatheter aortic valve implantation with both Edwards SAPIEN™ and Medtronic CoreValve ReValving System® devices: the Milan registry. EuroIntervention. 2011 Sep;7(5):556-63. doi: 10.4244/EIJV7I5A91. — View Citation
Hayashida K, Morice MC, Chevalier B, Hovasse T, Romano M, Garot P, Farge A, Donzeau-Gouge P, Bouvier E, Cormier B, Lefèvre T. Sex-related differences in clinical presentation and outcome of transcatheter aortic valve implantation for severe aortic stenosis. J Am Coll Cardiol. 2012 Feb 7;59(6):566-71. doi: 10.1016/j.jacc.2011.10.877. — View Citation
Kappetein AP, Head SJ, Généreux 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, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16. Review. — View Citation
Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VARC 2 | The primary study endpoint is the VARC 2 early safety endpoint at 30-days (all-cause mortality, all stroke [disabling and non disabling], life-threatening bleeding, stage 2 or 3 acute kidney injury [AKI], coronary artery obstruction requiring intervention, major vascular complications, repeat procedure for valve-related dysfunction). | 30 days | |
Secondary | VARC 2 | The clinical efficacy endpoint after 30-days (all-cause mortality, all stroke [disabling and non-disabling], requiring hospitalizations for valve related symptoms or worsening congestive heart failure, NYHA class III or IV, prosthetic valve dysfunction). | up to 2 years | |
Secondary | BARC | Additional individual safety endpoints include the following: all-cause mortality (procedural and 30-days), cardiovascular mortality, MI (peri-procedural and spontaneous), stroke (disabling and non-disabling), bleeding (life-threatening or disabling and major) and BARC type 3a-c and type 5a-b, AKI (stages 2 and 3), incidence of contrast-induced nephropathy, vascular complications (major and minor) and percutaneous closure device failure. | up to 2 years | |
Secondary | NYHA | The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying heart disease (originally cardiac failure), useful for preoperative assessment. It places patients in one of four categories, based on how much they are limited during physical activity: Class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities. Class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion. Class III: patients with marked limitation of activity; they are comfortable only at rest. Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest. |
up to 2 years | |
Secondary | KCCQ-12 | Kansas City Cardiomyopathy Questionnaire(KCCQ) - a shortened 12 question version of the 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | up to 2 years |
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