Women's INternational Transcatheter Aortic Valve Implantation Registry

Symptomatic Aortic Stenosis Clinical Trial

— WINTAVI  

Official title:

Women's INternational Transcatheter Aortic Valve Implantation Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819181
• Other study ID #: GCO 14-1774
• Status: Completed
• Start date: March 2013
• Est. completion date: April 26, 2018

Study information

• Verified date: May 2018
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Aortic Stenosis

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Society for Cardiovascular Angiography and Interventions

Countries where clinical trial is conducted

United States,  France,  Italy,  Netherlands,  Spain,  United Kingdom, 

References & Publications (4)

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

Outcome

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

External Links

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