NCT03495050

Brief Summary

Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 5, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2020

Completed
Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

1.7 years

First QC Date

March 3, 2018

Last Update Submit

June 16, 2026

Conditions

Bicuspid Aortic Valve

Keywords

BicuspidTAVITAVRself-expandingEvolut

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 Aortic Valve ImplantationDEVICE

Transcatheter treatment of bicuspid aortic stenosis with the Evolut Pro/XL platform

Also known as: Transcatheter Aortic Valve Replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Clinique Pasteur

Toulouse, Occitanie, 31076, France

Location

Related Publications (2)

  • Tchetche D, Ziviello F, De Biase C, De Backer O, Hovasse T, Leroux L, Petronio AS, Saint-Etienne C, Teles RC, Modine T, Sudre A, Teiger E, Mylotte D, Souteyrand G, Piazza N, Casassus F, Sondergaard L, Angelillis M, Nolasco T, Siddiqui S, Kardys I, Dumonteil N, Van Mieghem NM. Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry. EuroIntervention. 2023 Aug 21;19(6):502-511. doi: 10.4244/EIJ-D-23-00021.

    PMID: 37203860RESULT

  • 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

Bicuspid Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesAortic Valve DiseaseHeart Valve DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2018

First Posted

April 11, 2018

Study Start

June 5, 2018

Primary Completion

February 10, 2020

Study Completion

December 17, 2020

Last Updated

June 18, 2026

Record last verified: 2026-06

Locations

FR(1)