Brief Title
Outcome, Recuperation and Hemodynamics in Aortic Stenosis
Official Title
PRognosis of Outcome and Recuperation of Cardiac Hemodynamic Function After Aortic Valve REplacement in Aortic Valve Stenosis
Brief Summary
Indication for aortic valve replacement (AVR) in aortic stenosis (AS) is currently based on the classical triad of clinical AS symptoms, estimation of AS severity, and cardiac repercussion at rest. However, presence of symptoms in elderly is often subjective and underreported, and cardiac function analysis at rest underestimates the true impact of the chronic afterload increase. This complicates the diagnosis and hampers timely aortic valve replacement therapy with an impact on prognosis and cardiac function recovery. Exercise imaging in AS may reveal underlying cardiac repercussion and symptoms at an earlier stage and therefore impact prognosis and cardiac function recovery after AVR. Therefore the principal objective of this study is to reveal the factors that determine clinical outcome and hemodynamic function recovery after AVR in AS.
Study Type
Interventional
Primary Outcome
Outcome defined by the occurrence of a major cardiac event
Condition
Aortic Valve Stenosis
Intervention
CPET, 6MWT, QOL assessment
Study Arms / Comparison Groups
TAVI
Description: Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
150
Start Date
March 22, 2021
Completion Date
March 31, 2024
Primary Completion Date
September 30, 2023
Eligibility Criteria
Inclusion Criteria: - Every patient above 18 years of age with an echocardiographic established moderate to severe AS - A guideline indication for aortic valve replacement therapy Exclusion Criteria: - Unable to perform exercise testing - Previous aortic valve intervention - More than moderate other valvular disease - Patients refusing participation or unwilling to sign the informed consent
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lieven Herbots, MD PhD, +32498260617, [email protected]
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT05272020
Organization ID
f/2020/173
Responsible Party
Principal Investigator
Study Sponsor
Jessa Hospital
Study Sponsor
Lieven Herbots, MD PhD, Principal Investigator, Jessa Hospital
Verification Date
February 2022