BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience. (BIVOLUTX)
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|ClinicalTrials.gov Identifier: NCT03495050|
Recruitment Status : Unknown
Verified June 2018 by Didier TCHETCHE, Clinique Pasteur.
Recruitment status was: Recruiting
First Posted : April 11, 2018
Last Update Posted : June 12, 2018
|Condition or disease||Intervention/treatment|
|Bicuspid Aortic Valve||Device: Transcatheter Aortic Valve Implantation|
Study Design Study Design: prospective non-interventional multicenter registry Screening: MSCT submitted to core lab & sizing strategy pre-declared (annular sizing, supra-annular sizing, mix of both methods) Follow up: MSCT and TTE to cooper lab
TAVI treatment Predilatation according to aortic annulus Dmin Evolut Pro (23-26-29) and Evolut R 34 XL Annular anchoring of the THV Postdilatation according to the operators' discretion Study Population All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
Inclusion Criteria 1. Age ≥18 years. 2. NYHA≥2 and/or syncope and/or angina. 3. Patient judged by the Heart Team as indicated for TAVI. 4. Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.
5. Estimated life-expectancy>1 year.
Exclusion Criteria 1. Age <18 years 2. Asymptomatic patients 3. Estimated life expectancy<1 year 4. Pure aortic regurgitation. 5. LVEF<20% 6. No baseline MSCT evaluation. 7. Unsuitable aortic root anatomy for Evolut Pro or XL. 8. Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL. Primary Endpoint Valve performane Secondary endpoints 30 day and 1 year mortality Patient-prosthesis mismatch Ellipticity index at 30 days Follow-up 30 days: physical examination, ECG, TTE /MSCT upon operators' judgement
1 year: physical examination, ECG, TTE.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||150 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.|
|Actual Study Start Date :||February 21, 2018|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2020|
- Device: Transcatheter Aortic Valve Implantation
Transcatheter treatment of bicuspid aortic stenosis with the Evolut Pro/XL platformOther Name: Transcatheter Aortic Valve Replacement
- Valve performance [ Time Frame: 30 days ]effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate
- Valve performance [ Time Frame: one year ]effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate
- mortality [ Time Frame: 30 days and one year ]
- Patient-prosthesis mismatch [ Time Frame: 30 days and 1 year ]indexed effective area <0.65 cm2/m2
- Ellipticity index at 30 days [ Time Frame: 30 days ]
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 ClinicalTrials.gov identifier (NCT number): NCT03495050
|Contact: Didier TCHETCHE, MDfirstname.lastname@example.org|
|Contact: Didier TCHETCHE, MDemail@example.com|