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

This study is currently recruiting participants.
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

March 22, 2013
December 3, 2013
March 2013
September 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01819181 on ClinicalTrials.gov Archive Site
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.

Same as current
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.

Same as current
 
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.
 
Recruiting
1000
March 2019
September 2014   (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
Female
18 Years and older
No
Not Provided
France,   Germany,   Italy,   Latvia,   Netherlands,   Spain
 
NCT01819181
WIN TAVI
Yes
Society for Cardiovascular Angiography and Interventions
Society for Cardiovascular Angiography and Interventions
Mount Sinai School of Medicine
Principal Investigator: Alaide Chieffo, MD IRCCSSRaffaele and WINSCAI
Society for Cardiovascular Angiography and Interventions
December 2013

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