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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Didier TCHETCHE, Clinique Pasteur

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

Condition or disease Intervention/treatment
Bicuspid Aortic Valve 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Transcatheter Aortic Valve Implantation
    Transcatheter treatment of bicuspid aortic stenosis with the Evolut Pro/XL platform
    Other Name: Transcatheter Aortic Valve Replacement


Primary Outcome Measures :
  1. Valve performance [ Time Frame: 30 days ]
    effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate

  2. Valve performance [ Time Frame: one year ]
    effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate


Secondary Outcome Measures :
  1. mortality [ Time Frame: 30 days and one year ]
  2. Patient-prosthesis mismatch [ Time Frame: 30 days and 1 year ]
    indexed effective area <0.65 cm2/m2

  3. Ellipticity index at 30 days [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Didier TCHETCHE, MD 33562211699 d.tchetche@clinique-pasteur.com
Contact: Didier TCHETCHE, MD d.tchetche@clinique-pasteur.com

Locations
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France
Clinique Pasteur Recruiting
Toulouse, Occitanie, France, 31076
Contact: Didier TCHETCHE, MD    33562211699    d.tchetche@clinique-pasteur.com   
Contact: Didier TCHETCEH, MD    33562211699    d.tchetche@clinique-pasteur.com   
Sponsors and Collaborators
Clinique Pasteur
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Didier TCHETCHE, Head of structural heart disease program, Clinique Pasteur
ClinicalTrials.gov Identifier: NCT03495050    
Other Study ID Numbers: 2018-A00290-55
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Mutual ananymized database. Substudies anticipated.

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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
Keywords provided by Didier TCHETCHE, Clinique Pasteur:
Bicuspid
TAVI
TAVR
self-expanding
Evolut
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction