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Transcatheter Aortic Valve Implantation
TAVI vs SAVR for Aortic Stenosis (SURTAVI Trial)
N/A
Waitlist Available
Led By David H. Adams, MD
Research Sponsored by Medtronic Cardiovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has severe aortic stenosis presenting with critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index < 0.6cm2/m2 AND mean gradient > 40mmHg or Vmax > 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization [or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) <55%] or velocity ratio < 0.25.
Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months, 18 months, and 24 months. data for 3-5 years will be posted once data is complete
Awards & highlights
SURTAVI Trial Summary
This trial is investigating the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk. Patients will be randomized to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.
Who is the study for?
This trial is for people with severe, symptomatic Aortic Stenosis who are at intermediate risk for surgery. They must be of legal age to consent and have a predicted surgical mortality risk between ≥3% and <15%. Participants should commit to follow-up visits, not have had recent strokes or heart attacks, no severe lung disease (COPD), uncontrolled atrial fibrillation, or conditions that prevent anticoagulation.Check my eligibility
What is being tested?
The study compares the safety and effectiveness of two treatments: TAVI using Medtronic CoreValve® Systems versus traditional Surgical Aortic Valve Replacement (SAVR). Patients will either be randomly assigned to one of these treatments or receive TAVI in a non-randomized phase.See study design
What are the potential side effects?
Possible side effects include bleeding risks due to required anticoagulation therapy, potential reactions to materials like nitinol in the valve system, infection risks including endocarditis, and complications related to heart function post-procedure.
SURTAVI 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 with specific measurements.
Select...
I have symptoms from aortic valve stenosis and it affects my daily activities.
SURTAVI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 12 months, 18 months, and 24 months. data for 3-5 years will be posted once data is complete
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 12 months, 18 months, and 24 months. data for 3-5 years will be posted once data is complete
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability
Secondary outcome measures
Change in Distance Walked During 6-minute Walk Test (6MWT)
Change in NYHA Class From Baseline
Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance
+22 moreSURTAVI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Medtronic CoreValve® System TAVIExperimental Treatment2 Interventions
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Group II: SAVRActive Control1 Intervention
Surgical Aortic Valve Replacement (SAVR)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
2010
N/A
~4230
Find a Location
Who is running the clinical trial?
Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
34,586 Total Patients Enrolled
David H. Adams, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Rüdiger Lange, MD, PhDPrincipal InvestigatorDeutsches Herzzentrum München
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe liver failure.I have severe narrowing of my heart's aortic valve with specific measurements.My lung blood pressure is high.I am considered frail based on my age, mobility, living situation, weight, grip strength, daily activity ability, and protein levels.You have severe memory loss that makes it difficult for you to understand the trial or take care of yourself.I am on chronic dialysis or my kidneys filter less than 20 cc/min.You have a condition that means you can't get a bioprosthetic valve and need a mechanical valve instead.You have other health problems that make the surgery risk between 3% and 15% at 30 days according to the Heart Team.I have chosen not to undergo surgery for my aortic valve condition.I am allergic to blood thinners, nitinol, or contrast dyes and can't be treated for these allergies.I do not have severe blood disorders like very low white blood cells, platelets, or bleeding problems.I haven't had any heart or blood vessel procedures in the last 30 days.I have symptoms from narrowed neck arteries or had treatment for it within 6 weeks.I have severe heart failure requiring medication or mechanical support.I have not had a stroke or mini-stroke in the last 6 months.I am old enough to make my own medical decisions according to local laws.My doctors estimate I have less than 2 years to live due to other health issues.I have Marfan syndrome or a similar condition that requires surgery on the root of my aorta.I had a heart attack less than 30 days ago.I have severe COPD with very low lung function.My heart surgery risk has been evaluated by a team, including factors not covered by the STS score.A team of heart specialists agrees I am a good candidate for their proposed treatment.I have received extensive radiation therapy to the chest area.My heart often beats very fast, more than 120 times a minute.I do not have active bleeding in my stomach or intestines that would prevent blood thinning treatment.The medical team agrees that the aorta cannot be safely operated on for a specific type of heart surgery.My health condition might have other specific exclusions related to my body's structure and blood vessels.I need emergency surgery.I do not have an ongoing infection in my bloodstream or heart.My heart's pumping ability is significantly reduced.I refuse to receive blood transfusions.You have a medical condition that makes it unsafe for you to use external medical support.I have severe heart artery disease or issues with my heart's main artery.I have symptoms from aortic valve stenosis and it affects my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Medtronic CoreValve® System TAVI
- Group 2: SAVR
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.
Is the enrollment process still open for this study?
"According to clinicaltrials.gov, this specific trial has concluded its recruitment efforts as the study was posted in April 2012 and most recently updated on October 31st 2022. However, there are 307 other medical trials actively looking for participants at present."
Answered by AI
Are there numerous sites conducting this medical experiment in North America?
"Seventy different medical centres are participating in this research project, with a few noteworthy ones including Mount Sinai School of Medicine (Pittsburgh), University of Pittsburgh Medical Center (Danville), and Geisinger Medical Centre (Atlanta)."
Answered by AI
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