Clinical trial NCT01819181: Women's INternational Transcatheter Aortic Valve Implantation Registry
Official title: Women's INternational Transcatheter Aortic Valve Implantation Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Aortic Stenosis
Keywords: TAVI
women
aortic stenosis
VARC2
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Society for Cardiovascular Angiography and Interventions
First posted: 2013-03-27
Enrollment: 1019
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive female patients with severe symptomatic Aortic Stenosis who are deemed eligible for TAVI by a multi-disciplinary team in participating sites according to local policy.

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 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).

Eligibility criteria: 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

Primary outcomes:
measure: VARC 2
timeFrame: 30 days
Secondary outcomes:
measure: VARC 2
timeFrame: up to 2 years
measure: BARC
timeFrame: up to 2 years
measure: NYHA
timeFrame: up to 2 years
measure: KCCQ-12
timeFrame: up to 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Le Chesnay
country: France
facility: Hôpital Privé Parly 2
city: Catania
country: Italy
facility: Azienda Ospedaliero - Ferrarotto Alessi
city: Milan
country: Italy
facility: Instituto Clinico Humanitas
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Rome
country: Italy
facility: Department cardiovascular Sciences Policlinico Umberto I
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center Rotterdam
city: Zaragoza.
country: Spain
facility: Hospital Universitario Miguel Servet
city: London
country: United Kingdom
facility: Imperial College
Study officials:
affiliation: IRCCSSRaffaele and WINSCAI
name: Alaide Chieffo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Roxana Mehran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buchanan GL, Chieffo A, Montorfano M, Maisano F, Latib A, Godino C, Cioni M, Gullace MA, Franco A, Gerli C, Alfieri O, Colombo A. The role of sex on VARC outcomes following transcatheter aortic valve implantation with both Edwards SAPIEN and Medtronic CoreValve ReValving System(R) devices: the Milan registry. EuroIntervention. 2011 Sep;7(5):556-63. doi: 10.4244/EIJV7I5A91.
citation: Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.
citation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
citation: Hayashida K, Morice MC, Chevalier B, Hovasse T, Romano M, Garot P, Farge A, Donzeau-Gouge P, Bouvier E, Cormier B, Lefevre T. Sex-related differences in clinical presentation and outcome of transcatheter aortic valve implantation for severe aortic stenosis. J Am Coll Cardiol. 2012 Feb 7;59(6):566-71. doi: 10.1016/j.jacc.2011.10.877.