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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):
Roxana Mehran, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01819181
First received: March 22, 2013
Last updated: June 28, 2016
Last verified: June 2016
  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 Icahn School of Medicine at Mount Sinai:

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 [ Time Frame: up to 2 years ] [ 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).

  • BARC [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1019
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Primary Completion Date: May 2016 (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   (Adult, Senior)
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
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
France
Hôpital Privé Parly 2
Le Chesnay, France, 78150
Italy
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
Netherlands
Radboud University Nijmegen Medical Center
Radboud/Nijmegen, Netherlands, 9101
Erasmus Medical Center Rotterdam
Rotterdam, Netherlands, 3015 CE
Spain
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
Investigators
Principal Investigator: Alaide Chieffo, MD IRCCSSRaffaele and WINSCAI
Principal Investigator: Roxana Mehran, MD Icahn School of Medicine at Mount Sinai
  More Information

Additional Information:
Publications:

Responsible Party: Roxana Mehran, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01819181     History of Changes
Other Study ID Numbers: GCO 14-1774 
Study First Received: March 22, 2013
Last Updated: June 28, 2016
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 Icahn School of Medicine at Mount Sinai:
TAVI
women
aortic stenosis
VARC2

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 28, 2016