BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience. (BIVOLUTX)

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

Study Overview

• Status: Unknown
• Conditions: Bicuspid Aortic Valve
• Intervention / Treatment: Device: Transcatheter Aortic Valve Implantation

Detailed Description

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
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• France
  • Occitanie
    • Toulouse, Occitanie, France, 31076
      • Recruiting
      • Clinique Pasteur
      • Contact: Didier TCHETCHE, MD; Phone Number: 33562211699; Email: d.tchetche@clinique-pasteur.com
      • Contact: Didier TCHETCEH, MD; Phone Number: 33562211699; Email: d.tchetche@clinique-pasteur.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality		30 days and one year
Patient-prosthesis mismatch	indexed effective area <0.65 cm2/m2	30 days and 1 year
Ellipticity index at 30 days		30 days

Collaborators and Investigators

• Sponsor: Clinique Pasteur

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: March 3, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 10, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: TAVI; TAVR; Bicuspid; self-expanding; Evolut
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Aortic Valve Stenosis; Bicuspid Aortic Valve Disease
• Other Study ID Numbers: 2018-A00290-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Mutual ananymized database. Substudies anticipated.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No