Women's INternational Transcatheter Aortic Valve Implantation Registry (WINTAVI)
Symptomatic Aortic Stenosis
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||5 Years|
|Official Title:||Women's INternational Transcatheter Aortic Valve Implantation Registry|
- VARC 2 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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).
- VARC 2 [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]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).
- BARC [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]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.
- NYHA [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
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.
- KCCQ-12 [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2018|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01819181
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Hôpital Privé Parly 2|
|Le Chesnay, France, 78150|
|Azienda Ospedaliero - Ferrarotto Alessi|
|Catania, Italy, 95124|
|Instituto Clinico Humanitas|
|Milan, Italy, 20089|
|San Raffaele Hospital|
|Milan, Italy, 20132|
|Department cardiovascular Sciences Policlinico Umberto I|
|Radboud University Nijmegen Medical Center|
|Radboud/Nijmegen, Netherlands, 9101|
|Erasmus Medical Center Rotterdam|
|Rotterdam, Netherlands, 3015 CE|
|Hospital Universitario Miguel Servet|
|Zaragoza., Spain, 50009|
|London, United Kingdom, SW7 2AZ|
|Principal Investigator:||Alaide Chieffo, MD||IRCCSSRaffaele and WINSCAI|
|Principal Investigator:||Roxana Mehran, MD||Icahn School of Medicine at Mount Sinai|