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Transcatheter Aortic Valve Implantation

TAVI vs SAVR for Aortic Stenosis (SURTAVI Trial)

N/A
Waitlist Available
Led By Rüdiger Lange, MD, PhD
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.
Must not have
Liver failure (Child-C).
Pulmonary Hypertension (systolic pressure> 80mmHg).
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
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe narrowing of my heart's aortic valve with specific measurements.
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I have symptoms from aortic valve stenosis and it affects my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe liver failure.
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My lung blood pressure is high.
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I am on chronic dialysis or my kidneys filter less than 20 cc/min.
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I have chosen not to undergo surgery for my aortic valve condition.
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I am allergic to blood thinners, nitinol, or contrast dyes and can't be treated for these allergies.
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I do not have severe blood disorders like very low white blood cells, platelets, or bleeding problems.
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I have severe heart failure requiring medication or mechanical support.
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My doctors estimate I have less than 2 years to live due to other health issues.
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I had a heart attack less than 30 days ago.
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I have severe COPD with very low lung function.
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I have Marfan syndrome or a similar condition that requires surgery on the root of my aorta.
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I have received extensive radiation therapy to the chest area.
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My heart often beats very fast, more than 120 times a minute.
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I do not have active bleeding in my stomach or intestines that would prevent blood thinning treatment.
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I need emergency surgery.
Select...
I do not have an ongoing infection in my bloodstream or heart.
Select...
My heart's pumping ability is significantly reduced.
Select...
I refuse to receive blood transfusions.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 months, 18 months, and 24 months. data for 3-5 years will be posted once data is complete for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability
Secondary study objectives
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
+16 more

Awards & Highlights

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

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
34,421 Total Patients Enrolled
Patrick W. Serruys, MD, PhDStudy ChairNational Heart & Lung Institute of Imperial College in London
5 Previous Clinical Trials
4,614 Total Patients Enrolled
Nicolas M. Van Mieghem, MDStudy ChairErasmus Medical Center
Rüdiger Lange, MD, PhDPrincipal InvestigatorDeutsches Herzzentrum München
Thomas Walther, MD, PhDPrincipal InvestigatorKerckhoff Klinik
1 Previous Clinical Trials
Michael J. Reardon, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
1 Previous Clinical Trials
1,948 Total Patients Enrolled
David H. Adams, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Stephan Windecker, MD, PhDPrincipal InvestigatorBern University Hospital
2 Previous Clinical Trials
2,034 Total Patients Enrolled

Media Library

Medtronic CoreValve® Evolut R System (Transcatheter Aortic Valve Implantation) Clinical Trial Eligibility Overview. Trial Name: NCT01586910 — N/A
Aortic Stenosis Research Study Groups: Medtronic CoreValve® System TAVI, SAVR
Aortic Stenosis Clinical Trial 2023: Medtronic CoreValve® Evolut R System Highlights & Side Effects. Trial Name: NCT01586910 — N/A
Medtronic CoreValve® Evolut R System (Transcatheter Aortic Valve Implantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01586910 — N/A
~128 spots leftby Dec 2025
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