BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.

Bicuspid Aortic Valve Clinical Trial

— BIVOLUTX  

Official title:

BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03495050
• Other study ID #: 2018-A00290-55
• Status: Recruiting
• Start date: February 21, 2018
• Est. completion date: May 2020

Study information

• Verified date: June 2018
• Source: Clinique Pasteur
• Contact: Didier TCHETCHE, MD
• Phone: 33562211699
• Email: d.tchetche[@]clinique-pasteur.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Bicuspid Aortic Valve

Intervention

Device:
• Transcatheter Aortic Valve Implantation
Transcatheter treatment of bicuspid aortic stenosis with the Evolut Pro/XL platform

Locations

Country	Name	City	State
France	Clinique Pasteur	Toulouse	Occitanie

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Valve performance	effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate	30 days
Primary	Valve performance	effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate	one year
Secondary	mortality		30 days and one year
Secondary	Patient-prosthesis mismatch	indexed effective area <0.65 cm2/m2	30 days and 1 year
Secondary	Ellipticity index at 30 days		30 days