Women's INternational Transcatheter Aortic Valve Implantation Registry (WINTAVI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Society for Cardiovascular Angiography and Interventions
Sponsor:
Collaborator:
Mount Sinai School of Medicine
Information provided by (Responsible Party):
Society for Cardiovascular Angiography and Interventions
ClinicalTrials.gov Identifier:
NCT01819181
First received: March 22, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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


Condition
Symptomatic Aortic Stenosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Women's INternational Transcatheter Aortic Valve Implantation Registry

Resource links provided by NLM:


Further study details as provided by Society for Cardiovascular Angiography and Interventions:

Primary Outcome Measures:
  • VARC 2 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • VARC 2 and BARC [ Time Frame: 30 days, 6 month, 1 year up to 5 ] [ Designated as safety issue: Yes ]

    The clinical efficacy endpoint after 30-days (all-cause mortality, all stroke [disabling and non-disabling], requiring hospitalizations for valve related symptoms or worsening congestive heart failure, NYHA class III or IV, prosthetic valve dysfunction).

    Additional individual safety endpoints include the following: all-cause mortality (procedural and 30-days), cardiovascular mortality, MI (peri-procedural and spontaneous), stroke (disabling and non-disabling), bleeding (life-threatening or disabling and major) and BARC type 3a-c and type 5a-b, AKI (stages 2 and 3), incidence of contrast-induced nephropathy, vascular complications (major and minor) and percutaneous closure device failure.



Other Outcome Measures:
  • VARC 2, NYHA, KCCQ, six-minute walk test. [ Time Frame: 30 days, 6 month, 1 year up to 5 ] [ Designated as safety issue: Yes ]

    Additional prosthetic valve performance endpoints include the following: prosthetic valve stenosis, prosthesis-patient mismatch, prosthetic valve regurgitation (central and paravalvular), effective orifice area and mean gradient, prosthetic valve malpositioning, TAV-in TAV deployment, prosthetic valve thrombosis, prosthetic valve endocarditis.

    Additional TAVI related endpoints include the following: conduction disturbances and cardiac arrhythmias, coronary obstruction, conversion to open surgery, unplanned use of cardiopulmonary bypass, coronary obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction and cardiac tamponade.

    Additional clinical benefit endpoints include the following: NYHA functional assessment, Kansas City Cardiomyopathy Questionnaire(KCCQ) and six-minute walk test.



Estimated Enrollment: 1000
Study Start Date: March 2013
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819181

Locations
France
Clinique PASTEUR Recruiting
Toulouse, Midi-pyrenees, France, 31300
Contact: Didier Tchetche, MD       d.tchetche@clinique-pasteur.com   
Principal Investigator: Didier Tchetche, MD         
Hopital Jaques Cartier Recruiting
Massy, Paris, France, 91300
Contact: Thierry Lefevre, MD       t.lefevre@icps.com.fr   
Principal Investigator: Thierry Lefevre, MD         
Hôpital Privé Parly 2 Active, not recruiting
Le Chesnay, France, 78150
Centre Hospitalier Régional Universitaire de Lille Active, not recruiting
Lille Cedex, France, 59037
Rangueil Hospital Active, not recruiting
Toulouse, France, 50032
Germany
Deutsches Herzzentrum Munich Recruiting
Munich, Germany, 80636
Contact: Julinda Mehilli, MD    49891218    mehilli@dhm.mhn.de   
Principal Investigator: Julinda Mehilli, MD         
Italy
Azienda Ospedaliera Universitaria PO Ferrarotto Recruiting
Catania, Italy, 95124
Contact: Corrado Tamburino, MD PhD    00390957436205    tambucor@unict.it   
Principal Investigator: Corrado Tamburino, MD         
Istituto clinico humanitas Recruiting
Milan, Italy, 20089
Contact: Patrizia Presbitero, MD       patrizia.presbitero@humanitas.it   
Principal Investigator: Patrizia Presbitero, MD         
IRCCSSRaffaele Hospital Recruiting
Milan, Italy, 20132
Contact: Alaide Chieffo, MD    +390226437331 ext 7331    chieffo.alaide@hsr.it   
Principal Investigator: Alaide Chieffo, MD         
Department of Cardiac Thoracic and Vascular Sciences University of Padova Recruiting
Padova, Italy, 35139
Contact: Chiara Fraccaro, MD       chiara_fraccaro@hotmail.com   
Principal Investigator: Chiara Fraccaro, MD         
Azienda ospedaliera universitaria Pisana Sezione Dipartimentale Laboratorio di Emodinamica P.O. Cisanello Recruiting
Pisa, Italy, 56126
Contact: Anna Sonia Petronio, MD    050995244    as.petronio@gmail.com   
Principal Investigator: Anna Sonia Petronio, MD         
Department cardiovascular Sciences Policlinico Umberto I Recruiting
Rome, Italy
Contact: Gennaro Sardella, MD    00390649979035    rino.sardella@uniroma1.it   
Principal Investigator: Gennaro Sardella, MD         
Univerisity of Siena, Department of Cardiovascular Diseases,Hospital Santa Maria alle Scotte Active, not recruiting
Siena, Italy, 53100
Mauriziano Hospital Recruiting
Turin, Italy
Contact: Emanuele Meliga, MD       emeliga@gmail.com   
Principal Investigator: Emanuele Meliga, MD         
Latvia
Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital Active, not recruiting
Riga, Latvia, LV 1002
Pauls Stradins Clinical University Hospital Active, not recruiting
Riga, Latvia, LV 1002
Netherlands
Radboud University Nijmegen Medical Center Recruiting
Radboud/Nijmegen, Netherlands, 9101
Contact: Peter Kievit, MD       p.kievit@cardio.umcn.nl   
Principal Investigator: Peter Kievit, MD         
Erasmus Medical Center Rotterdam Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Nicolas Van Mieghem, MD       n.vanmieghem@erasmusmc.nl   
Principal Investigator: Nicolas Van Mieghem, MD         
Spain
Hospital Universitario Miguel Servet Recruiting
Zaragoza., Spain, 50009
Contact: Maria-Cruz Ferrer-Gracia       mcferrer10@gmail.com   
Principal Investigator: Isabel Calvo Cebollero, MD         
Sponsors and Collaborators
Society for Cardiovascular Angiography and Interventions
Mount Sinai School of Medicine
Investigators
Principal Investigator: Alaide Chieffo, MD IRCCSSRaffaele and WINSCAI
  More Information

Additional Information:
Publications:

Responsible Party: Society for Cardiovascular Angiography and Interventions
ClinicalTrials.gov Identifier: NCT01819181     History of Changes
Other Study ID Numbers: WIN TAVI
Study First Received: March 22, 2013
Last Updated: December 3, 2013
Health Authority: Italy: Ethics Committee
Spain: Ethics Committee
Germany: Ethics Commission
France: Conseil National de l'Ordre des Médecins
France: The Commission nationale de l’informatique et des libertés

Keywords provided by Society for Cardiovascular Angiography and Interventions:
TAVI
women
aortic stenosis
VARC2

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 18, 2014