BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
BIVOLUTX
1 other identifier
observational
150
1 country
1
Brief Summary
Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2018
CompletedFirst Submitted
Initial submission to the registry
March 3, 2018
CompletedFirst Posted
Study publicly available on registry
April 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedJune 12, 2018
June 1, 2018
1.2 years
March 3, 2018
June 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Valve performance
effective orifice area\<0.85 cm2/m2 and/or mean gradient\>20 mmHg and/or aortic regurgitation\>moderate
30 days
Valve performance
effective orifice area\<0.85 cm2/m2 and/or mean gradient\>20 mmHg and/or aortic regurgitation\>moderate
one year
Secondary Outcomes (3)
mortality
30 days and one year
Patient-prosthesis mismatch
30 days and 1 year
Ellipticity index at 30 days
30 days
Interventions
Transcatheter treatment of bicuspid aortic stenosis with the Evolut Pro/XL platform
Eligibility Criteria
All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
You may qualify if:
- Age ≥18 years.
- NYHA≥2 and/or syncope and/or angina.
- Patient judged by the Heart Team as indicated for TAVI.
- Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.
- Estimated life-expectancy\>1 year.
You may not qualify if:
- Age \<18 years
- Asymptomatic patients
- Estimated life expectancy\<1 year
- Pure aortic regurgitation.
- LVEF\<20%
- No baseline MSCT evaluation.
- Unsuitable aortic root anatomy for Evolut Pro or XL.
- Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clinique Pasteurlead
Study Sites (1)
Clinique Pasteur
Toulouse, Occitanie, 31076, France
Related Publications (1)
Tchetche D, de Biase C, van Gils L, Parma R, Ochala A, Lefevre T, Hovasse T, De Backer O, Sondergaard L, Bleiziffer S, Lange R, Kornowski R, Landes U, Norgaard BL, Biasco L, Philippart R, Molina-Martin de Nicolas J, Mylotte D, Lemee C, Dumonteil N, Van Mieghem NM. Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry. Circ Cardiovasc Interv. 2019 Jan;12(1):e007107. doi: 10.1161/CIRCINTERVENTIONS.118.007107.
PMID: 30626202DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of structural heart disease program
Study Record Dates
First Submitted
March 3, 2018
First Posted
April 11, 2018
Study Start
February 21, 2018
Primary Completion
May 1, 2019
Study Completion
May 1, 2020
Last Updated
June 12, 2018
Record last verified: 2018-06