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Transcatheter Aortic Valve Replacement

TAVR Valves for Aortic Valve Stenosis (SAVE Trial)

N/A
Waitlist Available
Led By Marvin Eng, MD
Research Sponsored by Marvin Eng
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic subjects with severe native aortic valve stenosis
Must not have
Patients with low-flow low gradient aortic valve stenosis
Intended concurrent structural heart procedure (e.g. transcatheter mitral valve repair or replacement, left atrial appendage closure)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days and 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at two types of valves used to treat heart conditions. The first type is called a supra-annular valve, and the second type is called an annular valve. The trial will compare how well each type of valve works in patients with small annuli (a heart condition that affects the size of the heart).

Who is the study for?
This trial is for individuals with severe aortic valve stenosis and an aortic valve annulus mean diameter of 23 mm or less. They must be symptomatic, meet the criteria for transcatheter aortic valve replacement (TAVR), and have suitable anatomy. Excluded are those who can't consent, are pregnant or planning pregnancy, at risk of coronary obstruction, have certain types of low-flow heart conditions, need other heart procedures, or have poor kidney function not managed by dialysis.
What is being tested?
The study compares two types of heart valves in patients with small annuli: Supra-annular valves (Medtronic Evolut Pro) versus annular valves (Edwards Sapien Ultra). It's an open-label trial where participants will know which treatment they receive and will be randomly assigned to one of the two options.
What are the potential side effects?
Potential side effects from these heart valve replacements may include bleeding complications, blood vessel complications related to the procedure itself, irregular heartbeat patterns that could require pacemaker placement after surgery, infection risks associated with any invasive procedure like TAVR.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe narrowing of my heart's aortic valve causing symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a specific heart valve condition with reduced blood flow.
Select...
I am scheduled for a heart procedure like valve repair or appendage closure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Pacemaker implantation
Prosthetic Valve Dysfunction
VARC-2 30-day early safety and efficacy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Supra-Annular transcatheter heart valveActive Control1 Intervention
Medtronic Evolut Pro Valve implantation
Group II: Annular transcatheter heart valveActive Control1 Intervention
Edwards Sapien 3 Ultra implantation

Find a Location

Who is running the clinical trial?

Marvin EngLead Sponsor
William Beaumont HospitalsOTHER
151 Previous Clinical Trials
112,460 Total Patients Enrolled
Marvin Eng, MDPrincipal Investigator - University of Arizona
Henry Ford Health System, Henry Ford Hospital, Henry Ford Macomb Hospital, Henry Ford West Bloomfield Hospital
Wayne State University School Of Medicine (Medical School)
University Co Hlth Sci Center (Residency)
1 Previous Clinical Trials

Media Library

Edwards Sapien Ultra (Transcatheter Aortic Valve Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT04372381 — N/A
Aortic Valve Stenosis Research Study Groups: Supra-Annular transcatheter heart valve, Annular transcatheter heart valve
Aortic Valve Stenosis Clinical Trial 2023: Edwards Sapien Ultra Highlights & Side Effects. Trial Name: NCT04372381 — N/A
Edwards Sapien Ultra (Transcatheter Aortic Valve Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04372381 — N/A
~27 spots leftby Nov 2025
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