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Trial record 1 of 1 for:    NCT01819181
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Women's INternational Transcatheter Aortic Valve Implantation Registry (WINTAVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01819181
Recruitment Status : Completed
First Posted : March 27, 2013
Last Update Posted : May 4, 2018
Society for Cardiovascular Angiography and Interventions
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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

Condition or disease
Symptomatic Aortic Stenosis

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).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1019 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Women's INternational Transcatheter Aortic Valve Implantation Registry
Study Start Date : March 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : April 26, 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. VARC 2 [ Time Frame: 30 days ]
    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 :
  1. VARC 2 [ Time Frame: up to 2 years ]
    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).

  2. BARC [ Time Frame: up to 2 years ]
    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.

  3. NYHA [ Time Frame: up to 2 years ]

    The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying heart disease (originally cardiac failure), useful for preoperative assessment. It places patients in one of four categories, based on how much they are limited during physical activity:

    Class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities.

    Class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion.

    Class III: patients with marked limitation of activity; they are comfortable only at rest.

    Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest.

  4. KCCQ-12 [ Time Frame: up to 2 years ]
    Kansas City Cardiomyopathy Questionnaire(KCCQ) - a shortened 12 question version of the 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01819181

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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Hôpital Privé Parly 2
Le Chesnay, France, 78150
Azienda Ospedaliero - Ferrarotto Alessi
Catania, Italy, 95124
Instituto Clinico Humanitas
Milan, Italy, 20089
San Raffaele Hospital
Milan, Italy, 20132
Department cardiovascular Sciences Policlinico Umberto I
Rome, Italy
Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 9101
Erasmus Medical Center Rotterdam
Rotterdam, Netherlands, 3015 CE
Hospital Universitario Miguel Servet
Zaragoza., Spain, 50009
United Kingdom
Imperial College
London, United Kingdom, SW7 2AZ
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Society for Cardiovascular Angiography and Interventions
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Principal Investigator: Alaide Chieffo, MD IRCCSSRaffaele and WINSCAI
Principal Investigator: Roxana Mehran, MD Icahn School of Medicine at Mount Sinai
Additional Information:


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Responsible Party: Icahn School of Medicine at Mount Sinai Identifier: NCT01819181    
Other Study ID Numbers: GCO 14-1774
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Keywords provided by Icahn School of Medicine at Mount Sinai:
aortic stenosis
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction