Women's INternational Transcatheter Aortic Valve Implantation Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1019 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2018-04-26

Brief Summary

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

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Detailed Description

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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).

Conditions

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Symptomatic Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No