Women's INternational Transcatheter Aortic Valve Implantation Registry

NCT01819181 | Completed DMC

• 1 other identifier: GCO 14-1774
• Study Type: observational
• Target: 1,019
• Locations: 6 countries
• Sites: 10

Brief Summary

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

Conditions

Symptomatic Aortic Stenosis

Keywords

TAVI; women; aortic stenosis; VARC2

Outcome Measures

Primary Outcomes (1)

• VARC 2

  The primary study endpoint is the VARC 2 early safety endpoint at 30-days (all-cause mortality, all stroke \[disabling and non disabling\], life-threatening bleeding, stage 2 or 3 acute kidney injury \[AKI\], coronary artery obstruction requiring intervention, major vascular complications, repeat procedure for valve-related dysfunction).

  30 days

Secondary Outcomes (4)

• VARC 2

  up to 2 years

• BARC

  up to 2 years

• NYHA

  up to 2 years

• KCCQ-12

  up to 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Society for Cardiovascular Angiography and Interventions: collaborator

Study Sites (10)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Hôpital Privé Parly 2

Le Chesnay, 78150, France

Location

Azienda Ospedaliero - Ferrarotto Alessi

Catania, 95124, Italy

Location

Instituto Clinico Humanitas

Milan, 20089, Italy

Location

San Raffaele Hospital

Milan, 20132, Italy

Location

Department cardiovascular Sciences Policlinico Umberto I

Rome, Italy

Location

Radboud University Nijmegen Medical Center

Nijmegen, 9101, Netherlands

Location

Erasmus Medical Center Rotterdam

Rotterdam, 3015 CE, Netherlands

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Imperial College

London, SW7 2AZ, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 21930459 BACKGROUND

• 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.

  PMID: 23084102 BACKGROUND

• 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.

  PMID: 21670242 BACKGROUND

• 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.

  PMID: 22300690 BACKGROUND

Related Links

• Women in Innovations ("WIN") mission is to address sex-based disparities in cardiovascular diagnosis, treatment and outcomes through innovative educational and research activities.

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Alaide Chieffo, MD

  IRCCSSRaffaele and WINSCAI

  PRINCIPAL INVESTIGATOR

• Roxana Mehran, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: March 27, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: April 26, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

FR (1); GB (1); IT (4); NL (2); US (1); ES (1)