Women's INternational Transcatheter Aortic Valve Implantation Registry (WINTAVI)

The study will evaluate all female patients with severe aortic stenosis undergoing transcatheter valve implantation with commercially available valves and delivery systems.

Study Overview

• Status: Completed
• Conditions: Symptomatic Aortic Stenosis

Detailed Description

WINTAVI is an international, multi-centre, prospective, observational registry. The purpose of this study is to collect 'real-world' data regarding the clinical utility of all commercially available Transcatheter Aortic Valve Implantation (TAVI) devices for percutaneous aortic valve implantation in female patients with severe Aortic Stenosis (AS) requiring treatment. Data collected in this study will provide additional information on the understanding of the safety and device performance in a 'real-world' setting and how to best treat patients with severe AS. This will include Quality of Life questionnaires (KCCQ).

• Study Type: Observational
• Enrollment (Actual): 1019

Contacts and Locations

Study Locations

• France
  • Le Chesnay, France, 78150
    • Hôpital Privé Parly 2
• Italy
  • Catania, Italy, 95124
    • Azienda Ospedaliero - Ferrarotto Alessi
  • Milan, Italy, 20132
    • San Raffaele Hospital
  • Milan, Italy, 20089
    • Instituto Clinico Humanitas
  • Rome, Italy
    • Department cardiovascular Sciences Policlinico Umberto I
• Netherlands
  • Nijmegen, Netherlands, 9101
    • Radboud University Nijmegen Medical Center
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medical Center Rotterdam
• Spain
  • Zaragoza., Spain, 50009
    • Hospital Universitario Miguel Servet
• United Kingdom
  • London, United Kingdom, SW7 2AZ
    • Imperial College
• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Consecutive female patients with severe symptomatic Aortic Stenosis who are deemed eligible for TAVI by a multi-disciplinary team in participating sites according to local policy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Society for Cardiovascular Angiography and Interventions
• Investigators: Principal Investigator: Alaide Chieffo, MD, IRCCSSRaffaele and WINSCAI

Publications and helpful links

General Publications

• 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. No abstract available.
• 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-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.
• 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(R) devices: the Milan registry. EuroIntervention. 2011 Sep;7(5):556-63. doi: 10.4244/EIJV7I5A91.
• Hayashida K, Morice MC, Chevalier B, Hovasse T, Romano M, Garot P, Farge A, Donzeau-Gouge P, Bouvier E, Cormier B, Lefevre 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.

Helpful Links

• Women in Innovations ("WIN") mission is to address sex-based disparities in cardiovascular diagnosis, treatment and outcomes through innovative educational and research activities.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): April 26, 2018

Study Registration Dates

• First Submitted: March 22, 2013
• First Submitted That Met QC Criteria: March 26, 2013
• First Posted (Estimate): March 27, 2013

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: women; aortic stenosis; TAVI; VARC2
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: GCO 14-1774