Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05836363
Other study ID # NO SVAO-BAV
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 4, 2020
Est. completion date December 9, 2020

Study information

Verified date April 2023
Source Ospedale San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Aortic valve bicuspid disease is the most common congenital heart disease. It affects 0.5-2% of the population and is associated with an increased risk of developing aortic or ascending aortic valve complications. There is no agreement regarding the opportunity for a "prophylactic" simultaneous aortic valve replacement in the case of mild or moderate aortic valve disease in the bicuspid valve, in patients with an indication for replacement of the ascending aorta due to an aneurysm involving its supra-coronary tract. The aim of this study is to evaluate the long-term evolution of mild and moderate aortic valve disease in untreated bicuspid valve during supracoronary ascending aortic replacement surgery at our institution.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date December 9, 2020
Est. primary completion date December 9, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients; - Bicuspid aortic valve; - Presence of ascending aortic aneurysm in the supra-coronary tract treated with replacement using a prosthetic tube between 2002 and January 2020; - Untreated aortic valve disease of no more than moderate degree (<2+) at the time of ascending aorta surgery. Exclusion Criteria: - Emergency/urgency procedures; - Presence of aneurysm extending to the aortic arch or aortic root, with indication for aortic root or aortic arch surgery; - Tricuspid aortic valve tricuspid; - Absence of aortic valve disease; - Presence of moderate-severe or severe aortic valve disease, with indication to a concomitant aortic valve replacement.

Study Design


Intervention

Procedure:
Ascending aorta replacement
The aneurysmatic ascending aorta tract is replaced with a tubular dacron prosthesis

Locations

Country Name City State
Italy IRCCS Ospedale San Raffaele Milan

Sponsors (1)

Lead Sponsor Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Aortic valve regurgitation Through study completion, a minimum of 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT01390181 - The Effect of Losartan in Bicuspid Aortic Valve Patients N/A
Enrolling by invitation NCT06212050 - Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Active, not recruiting NCT03635424 - Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study N/A
Recruiting NCT06153407 - Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve
Active, not recruiting NCT03474159 - Evaluation of Aortic Stiffness as a Prognostic Indicator of Aortic Dilatation in Patients With Bicuspid Aortic Valve by Multimodal Imaging N/A
Not yet recruiting NCT06375590 - NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience
Recruiting NCT05739253 - Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
Completed NCT01823432 - Genetic Risks for Bicuspid Aortic Valve Disease
Completed NCT02679261 - Evaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular Degeneration in Patients With Bicuspid Aortic Valve Phase 3
Completed NCT01920815 - Bicuspid Valve Aortopathy Feasibility Study
Recruiting NCT04817735 - The CASPER Registry N/A
Recruiting NCT02899624 - Whole Exome Sequencing in Bicuspid Aortic Valve Patients N/A
Recruiting NCT05708118 - Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
Recruiting NCT03495050 - BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
Completed NCT01760668 - Aortopathy in Persons With Bicuspid Aortic Valve, Turner and Marfan Syndrome N/A
Not yet recruiting NCT05711693 - Measurement of Heart-carotid Pulse Wave Velocity (hcPWV) by Laser Doppler Vibrometry (LDV) N/A
Completed NCT02283970 - Investigation of Patients With BAV Requiring Valve and/or Aortic Repair (GISSI Outliers VAR)
Active, not recruiting NCT01026571 - Identification of Genetic Causes of Bicuspid Aortic Valve Disease
Completed NCT00412386 - Abnormal 3-D MRI Flow Patterns in Adolescents Patients With Bicuspid Aortic Valve N/A
Recruiting NCT03440697 - Pathogenetic Basis of Aortopathy and Aortic Valve Disease