Women's INternational Transcatheter Aortic Valve Implantation Registry

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).

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