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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
SAVE Trial 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.Check my eligibility
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.See study design
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.
SAVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe narrowing of my heart's aortic valve causing symptoms.
SAVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation
Secondary outcome measures
Pacemaker implantation
Prosthetic Valve Dysfunction
VARC-2 30-day early safety and efficacy
SAVE 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
149 Previous Clinical Trials
112,708 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart team has approved me for a valve replacement without open surgery.I have severe narrowing of my heart's aortic valve causing symptoms.I have a specific heart valve condition with reduced blood flow.The width of your aortic valve is less than 23 millimeters.Your body is suitable for using either the Medtronic Evolute or Edwards Sapien 3 Ultra heart valve.You need a transcatheter aortic valve replacement for a specific medical reason.I am scheduled for a heart procedure like valve repair or appendage closure.You have a high chance of having a blocked blood vessel in your heart.My kidneys work well enough for iodinated contrast, or I'm on dialysis.You are at high risk for a tear in the heart valve when getting a specific type of valve implanted.
Research Study Groups:
This trial has the following groups:- Group 1: Supra-Annular transcatheter heart valve
- Group 2: Annular transcatheter heart valve
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been enlisted in this clinical experiment?
"Affirmative. Clinicaltrials.gov is currently showcasing information which reflects that this medical research project was first published on May 4th 2020, and has been modified recently on April 29th 2020. The objective of the trial is to enrol 150 patients at one site."
Answered by AI
Are there any open positions left for participants in this clinical research?
"Affirmative. Clinicaltrials.gov attests that this research project, which was initially advertised on May 4th 2020, is actively seeking volunteers. Around 150 candidates need to be enrolled from a single healthcare facility."
Answered by AI
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