Your session is about to expire
← Back to Search
Transcatheter Valve Replacement
TAVR vs SAVR for Aortic Valve Stenosis
N/A
Waitlist Available
Led By John K. Forrest, MD
Research Sponsored by Medtronic Cardiovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Severe aortic stenosis with specific echocardiographic criteria for symptomatic and asymptomatic patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is comparing the safety and effectiveness of the Medtronic TAVR system to SAVR in the treatment of severe aortic stenosis in low risk patients. The continued access phase will be single-arm and non-randomized.
Who is the study for?
This trial is for people with severe aortic stenosis who are considered low risk for surgical valve replacement. They must meet specific heart criteria, agree to follow-up visits, and not have conditions that conflict with the treatment like blood disorders or recent major health events.Check my eligibility
What is being tested?
The study compares the Medtronic TAVR system's safety and effectiveness against traditional surgery in treating severe aortic stenosis at two years. It includes an initial randomized phase followed by a single-arm continued access phase.See study design
What are the potential side effects?
Potential side effects may include risks associated with heart valve procedures such as bleeding, stroke, infections, irregular heart rhythms, or issues related to the prosthetic valve function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe narrowing of the heart's aortic valve.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study
Secondary outcome measures
All Stroke (Disabling and Non-disabling) at 1 Year
Life-threatening Bleeding at 1 Year
New Pacemaker Implantation at 30 Days
+7 moreOther outcome measures
Efficacy: Device Success Rate
Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial
Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Effective Orifice Area (EOA) at 1 Year
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Medtronic Transcatheter Aortic Valve Replacement SystemsExperimental Treatment1 Intervention
Treatment of Aortic Stenosis with the Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) device or the Medtronic Corevalve Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Group II: Surgical Aortic Valve Replacement (SAVR)Active Control1 Intervention
Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR)
Find a Location
Who is running the clinical trial?
Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
34,109 Total Patients Enrolled
22 Trials studying Aortic Valve Stenosis
13,407 Patients Enrolled for Aortic Valve Stenosis
John K. Forrest, MDPrincipal InvestigatorYale New Haven Hospital
Michael Reardon, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
5 Previous Clinical Trials
2,405 Total Patients Enrolled
3 Trials studying Aortic Valve Stenosis
2,105 Patients Enrolled for Aortic Valve Stenosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have blood disorders, ongoing severe infections, recent strokes, or symptomatic artery disease in my neck.I am not pregnant, in another drug trial, needing emergency surgery, or recently had a heart attack.I have a serious heart condition or an unsuitable heart structure for certain treatments.You are not suitable for receiving a bioprosthetic valve.I have severe narrowing of the heart's aortic valve.You have other health, social, or emotional issues that might make it hard for you to understand and follow the study guidelines.You have severe heart problems, recent stomach bleeding, severe memory loss, or are expected to live less than 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical Aortic Valve Replacement (SAVR)
- Group 2: Medtronic Transcatheter Aortic Valve Replacement Systems
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.
Are applications still being accepted for this clinical investigation?
"According to clinicaltrials.gov, this medical trial is not recruiting participants at the moment. The trial was initially published on March 1st 2016 and last updated October 24th 2022; however, there are 161 other studies actively looking for patients as of now."
Answered by AI
How widespread is the implementation of this experiment?
"Patients are being enrolled in this trial from Good Samaritan Hospital, The Ohio State University, and Baylor Jack and Jane Hamilton Heart and Vascular Hospital. Additionally, there are 67 other medical centres offering involvement in the study."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger