Clinical Trial

Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis

Study acronym: NOTION-2
Active, Not Recruiting
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Summary
A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve stenosis. Study hypothesis: The clinical outcome (death of any cause, stroke and rehospitalization (related to the procedure, valve or heart failure)) obtained within one year after TAVR is non-inferior to SAVR.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2016-07-03; most recent amendment 2024-04-06.
Status change: Recruiting → Active, Not Recruiting 2024-02-27
Trial Details
NCT Number NCT02825134
Lead Sponsor Ole De Backer
Collaborators: Symetis SA, Boston Scientific Corporation, Abbott, Edwards Lifesciences
Conditions Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Ventricular Outflow Obstruction
Enrollment 376 participants
Start Date 2016-06-30
Primary Completion 2024-02 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2024-04-09