Women's INternational Transcatheter Aortic Valve Implantation Registry

Completed

Conditions studied: Symptomatic Aortic Stenosis

In brief

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

Key facts

Study ID

NCT01819181

Run by

Icahn School of Medicine at Mount Sinai

People needed

1019

Starts

2013-03-01

Expected to finish

2018-04-26

Last updated by the study team

2018-05-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Hôpital Privé Parly 2 — Le Chesnay, France
• Azienda Ospedaliero - Ferrarotto Alessi — Catania, Italy
• Instituto Clinico Humanitas — Milan, Italy
• San Raffaele Hospital — Milan, Italy
• Department cardiovascular Sciences Policlinico Umberto I — Rome, Italy
• Radboud University Nijmegen Medical Center — Nijmegen, Netherlands
• Erasmus Medical Center Rotterdam — Rotterdam, Netherlands
• Hospital Universitario Miguel Servet — Zaragoza, Spain
• Imperial College — London, United Kingdom

Full record on ClinicalTrials.gov

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