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Transcatheter Valve Replacement

TAVR vs SAVR for Aortic Valve Stenosis

N/A

Waitlist Available

Led By Michael Reardon, 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

Must not have

Blood dyscrasias, ongoing sepsis, recent cerebrovascular accident, or symptomatic carotid or vertebral artery disease

Participation in another investigational drug or device trial, evidence of acute myocardial infarction, need for emergency surgery, pregnancy, legal incompetence, or vulnerability

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have severe narrowing of the heart's aortic valve.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have blood disorders, ongoing severe infections, recent strokes, or symptomatic artery disease in my neck.

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I am not pregnant, in another drug trial, needing emergency surgery, or recently had a heart attack.

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I have a serious heart condition or an unsuitable heart structure for certain treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

All Stroke (Disabling and Non-disabling) at 1 Year

Life-threatening Bleeding at 1 Year

New Pacemaker Implantation at 30 Days

+7 more

Other study objectives

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 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 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)

0 / 4Eligibility criteria met