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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Society for Cardiovascular Angiography and Interventions
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01819181
First received: March 22, 2013
Last updated: January 26, 2017
Last verified: January 2017
March 22, 2013
January 26, 2017
March 2013
May 2016   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01819181 on ClinicalTrials.gov Archive Site
  • 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).
  • 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.
  • 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.

  • 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.
VARC 2 and BARC [ Time Frame: 30 days, 6 month, 1 year up to 5 ]

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.

Not Provided
VARC 2, NYHA, KCCQ, six-minute walk test. [ Time Frame: 30 days, 6 month, 1 year up to 5 ]

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.

 
Women's INternational Transcatheter Aortic Valve Implantation Registry
Women's INternational Transcatheter Aortic Valve Implantation Registry
The study will evaluate all female patients with severe aortic stenosis undergoing transcatheter valve implantation with commercially available valves and delivery systems.
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).
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
5 Years
Not Provided
Non-Probability Sample
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.
Symptomatic Aortic Stenosis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1019
March 2018
May 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   Netherlands,   Spain,   United Kingdom,   United States
Germany,   Latvia
 
NCT01819181
GCO 14-1774
Yes
Not Provided
Not Provided
Not Provided
Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
Society for Cardiovascular Angiography and Interventions
Principal Investigator: Alaide Chieffo, MD IRCCSSRaffaele and WINSCAI
Principal Investigator: Roxana Mehran, MD Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP