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Completed

NCT Number: NCT01819181

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.

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Key information

Conditions

Symptomatic Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Privé Parly 2, Le Chesnay, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Society for Cardiovascular Angiography and Interventions

Registry information

Acronym: WINTAVI

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
Mar 27, 2013
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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