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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.

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I do not have an ongoing infection in my bloodstream or heart.

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My heart's pumping ability is significantly reduced.

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I refuse to receive blood transfusions.

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

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.