Status:
COMPLETED
Women's INternational Transcatheter Aortic Valve Implantation Registry
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Society for Cardiovascular Angiography and Interventions
Conditions:
Symptomatic Aortic Stenosis
Eligibility:
FEMALE
18+ years
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 T...
Eligibility Criteria
Inclusion
- 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
- Symptomatic AS demonstrated by angina, congestive heart failure, NYHA functional class ≥ II, or syncope
- Logistic EuroSCORE suitable for TAVI
- 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.
- Patient has been informed of the nature of the registry and has provided full written informed consent according to hospital practise
Exclusion
- Patient is not an eligible candidate for TAVI
- Untreated clinically significant (\> 70% obstruction) coronary artery disease in the proximal segments of main branches suitable for revascularization
- Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
- Hemodynamic instability (e.g. requiring inotropic support)
- Active endocarditis or sepsis within 6-months prior to the study procedure
- Use of investigational device without CE mark
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 26 2018
Estimated Enrollment :
1019 Patients enrolled
Trial Details
Trial ID
NCT01819181
Start Date
March 1 2013
End Date
April 26 2018
Last Update
May 4 2018
Active Locations (10)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
2
Hôpital Privé Parly 2
Le Chesnay, France, 78150
3
Azienda Ospedaliero - Ferrarotto Alessi
Catania, Italy, 95124
4
Instituto Clinico Humanitas
Milan, Italy, 20089