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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bicuspid aortic valve | Treated with Navitor platform |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Aortic Valve Implantation | Device | Transcatheter treatment of bicuspid stenosis with the Navitor platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day device success (Rate) | as indicated in the VARC-3 criteria | 30-day |
| Measure | Description | Time Frame |
|---|---|---|
| 1 year at least moderate bioprosthetic valve deterioration | defined as increase in mean transvalvular gradient ≥10 mmHg resulting in mean gradient ≥20 mmHg with concomitant decrease in EOA ≥0.3 cm2 or ≥25% and/or decrease in Doppler velocity index ≥0.1 or ≥20% compared with echocardiographic assessment performed 1-3 months post-procedure, OR new occurrence or increase of ≥1 grade of intra-prosthetic AR resulting in ≥ moderate AR |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Didier Tchétché, MD | Contact | +33562211699 | d.tchetche@clinique-pasteur.com |
| Name | Affiliation | Role |
|---|---|---|
| Didier Tchétché, MD | Clinique Pasteur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Pasteur | Toulouse | Occitanie | 31076 | France |
Mutual anonymized database. Substudies anticipated.
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| ID | Term |
|---|---|
| D000082882 | Bicuspid Aortic Valve Disease |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 1-year |
| 1 year severe patient-prosthesis mismatch | defined as EOAi < 0.65 cm2/m2 | 1-year |
| 30 days and 1 year all-cause and cardiovascular mortality | 1-year |
| 30 days and 1 year stroke | 1-year |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |