TAVR for Aortic Stenosis
(EARLY TAVR Trial)
Recruiting at 77 trial locations
EL
JT
ET
Overseen ByEdwards THV Clinical Affairs
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Edwards Lifesciences
No Placebo Group
Trial Summary
What is the purpose of this trial?
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
Research Team
PG
Philippe Généreux, MD
Principal Investigator
Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation
Eligibility Criteria
This trial is for people aged 65 or older with severe, calcific aortic stenosis who show no symptoms and have an ejection fraction of at least 50%. Participants must be able to give informed consent and have an STS risk score ≤10. It's not for those with symptomatic heart conditions, other diseases requiring surgery, certain valve anomalies, recent heart attacks or strokes, bleeding disorders, severe lung disease or infections like COVID-19.Inclusion Criteria
I have been diagnosed with severe narrowing of the aortic valve.
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
I do not have any symptoms.
See 3 more
Exclusion Criteria
You have a serious problem with a heart valve called the aortic valve.
I haven't needed heart or lung support machines in the last 30 days.
You have a pre-existing mechanical or bioprosthetic heart valve.
See 27 more
Treatment Details
Interventions
- Edwards SAPIEN 3 / SAPIEN 3 Ultra THV (Transcatheter Heart Valve)
Trial OverviewThe study compares the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) implantation against regular clinical surveillance in patients without symptoms but diagnosed with severe aortic stenosis. The goal is to assess if early intervention with THV improves outcomes compared to just monitoring the condition.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: TAVRExperimental Treatment1 Intervention
Transcatheter aortic valve replacement (TAVR)
Group II: CSActive Control1 Intervention
Clinical surveillance (CS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edwards Lifesciences
Lead Sponsor
Trials
188
Recruited
67,500+
Founded
1958
Headquarters
Irvine, California, U.S.
Known For
Structural Heart Innovations
Top Products
SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3
Todd Brinton
Edwards Lifesciences
Chief Medical Officer since 2023
MD from Stanford University
Bernard Zovighian
Edwards Lifesciences
Chief Executive Officer since 2023
MBA from INSEAD