Women's INternational Transcatheter Aortic Valve Implantation Registry

Completed

• Conditions: Symptomatic Aortic Stenosis

• Registration Number: NCT01819181
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-22
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-27
• Primary Completion: 2016-05
• Study Completion: 2018-04-26
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1019

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VARC 2	30 days	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).

Secondary Outcome Measures

Name	Time	Method
VARC 2	up to 2 years	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	up to 2 years	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	up to 2 years	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	up to 2 years	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.

Trial Locations

Locations (10)

Instituto Clinico Humanitas; 🇮🇹 Milan, Italy

Hôpital Privé Parly 2; 🇫🇷 Le Chesnay, France

Imperial College; 🇬🇧 London, United Kingdom

Department cardiovascular Sciences Policlinico Umberto I; 🇮🇹 Rome, Italy

Azienda Ospedaliero - Ferrarotto Alessi; 🇮🇹 Catania, Italy

Radboud University Nijmegen Medical Center; 🇳🇱 Nijmegen, Netherlands

Erasmus Medical Center Rotterdam; 🇳🇱 Rotterdam, Netherlands

San Raffaele Hospital; 🇮🇹 Milan, Italy

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza., Spain