Overview

This trial is active, not recruiting.

Condition symptomatic aortic stenosis
Sponsor Icahn School of Medicine at Mount Sinai
Collaborator Society for Cardiovascular Angiography and Interventions
Start date March 2013
End date May 2016
Trial size 1019 participants
Trial identifier NCT01819181, GCO 14-1774

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
VARC 2
time frame: 30 days

Secondary Outcomes

Measure
VARC 2
time frame: up to 2 years
BARC
time frame: up to 2 years
NYHA
time frame: up to 2 years
KCCQ-12
time frame: up to 2 years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Women's INternational Transcatheter Aortic Valve Implantation Registry
Principal investigator Alaide Chieffo, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai.