CLINICAL STUDY RESULTS TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR)

Medtronic TAVR Clinical Data

Several clinical trials have been conducted to provide information about the chance of a risk from the Medtronic TAVR procedure. The following chart shows 30-day or 1-year results from these clinical trials.

TAVR currently is approved for patients with severe aortic stenosis who are at intermediate risk, high risk, or extreme risk for complications during surgery. A number of factors determines a patient’s risk including age and other medical conditions that make surgery more dangerous. Your doctor will let you know which risks most likely apply to you based on the patient groups below.

  Risks within 30 days Risks within 1 year
Trial Name Evolut PRO Clinical Study SURTAVI Trial Evolut R Clinical Study CoreValve U.S. Pivotal Study CoreValve U.S. Pivotal Study
Patient Group with Aortic Stenosis High/Extreme Risk Patients Intermediate Risk Patients High/Extreme Risk Patients High Risk Patients Extreme Risk Patients
Death from any cause 2 out of 100 Patients 7 out of 100 Patients 8 out of 100 Patients 14 out of 100 Patients 26 out of 100 Patients
Death from a heart- related cause 2 out of 100 Patients 5 out of 100 Patients 7 out of 100 Patients 10 out of 100 Patients 18 out of 100 Patients
Disabling stroke 0 out of 100 Patients 2 out of 100 Patients 5 out of 100 Patients 6 out of 100 Patients 4 out of 100 Patients
New permanent pacemaker 12 out of 100 Patients 31 out of 100 Patients 19 out of 100 Patients 29 out of 100 Patients 26 out of 100 Patients
Life threatening or disabling bleeding 13 out of 100 Patients 7 out of 100 Patients 10 out of 100 Patients 15 out of 100 Patients 18 out of 100 Patients
Major vascular complications 9 out of 100 Patients 6 out of 100 Patients 7 out of 100 Patients 6 out of 100 Patients 8 out of 100 Patients
Heart attack (myocardial infarction) 0 out of 100 Patients 2 out of 100 Patients 1 out of 100 Patients 2 out of 100 Patients 2 out of 100 Patients
Valve inflammation or infection (endocarditis) 0 out of 100 Patients 0 out of 100 Patients 0 out of 100 Patients 1 out of 100 Patients 1 out of 100 Patients

Clinical Trial Summaries

Evolut  PRO System Study Overview

These patients were at high risk or were too sick for surgery. This group included 45 patients at 8 hospitals in the United States.

Patients were seen at:

  • 30 days
  • 6 months

Patients will be seen at:

  • 1 year

Yearly checkups will continue for 5 years.

The study results showed:

  • The Evolut™ PRO valve works like the previous generation CoreValve™ and Evolut R heart valves.
  • The Evolut PRO valve was found reasonably safe and effective.

SURTAVI Intermediate Risk Study

These patients were at Intermediate Risk for surgery. The trial included 1,660 patients at 87 hospitals in the United States, Europe, and Canada. Patients were randomly put in the Medtronic TAVR procedure or surgery group.

Patients were seen at:

  • 30 days
  • 6 months
  • 1 year

Yearly checkups will continue for 10 years.

The study results showed:

The CoreValve and Evolut R heart valves were found to have an acceptable safety profile

and were effective in treating severe aortic stenosis patients at intermediate risk.

Evolut R Study Overview

These patients were at high risk or were too sick for surgery. This group included 151 patients at 24 hospitals in the United States, Australia, New Zealand, and the UK.

Patients were seen at:

  • 30 days
  • 6 months
  • 1 year

Yearly checkups will continue for 5 years.

The study results showed:

  • The Evolut R valve works like the CoreValve heart valve.
  • The Evolut R valve was found reasonably safe and effective.

High Risk Study Overview

These patients were at high risk for surgery. This group included 747 patients at 45 hospitals in the United States. 

Most received the CoreValve heart valve through an artery in their leg. Some received it through a space between their ribs and others through an artery in their neck. Patients were randomly put in the CoreValve procedure or surgery group.

Patients were seen at:

  • 30 days
  • 6 months
  • 1 year

Yearly checkups will continue for 5 years.

The study results at 1 year showed:

  • The CoreValve procedure had an acceptable safety profile and was an effective alternative to surgery.
  • More CoreValve heart valve patients were alive than surgical patients.

Extreme Risk Study Overview

These patients were too sick for surgery. This group included 639 patients at 41 hospitals in the United States.

Four hundred eighty-nine (489) received the CoreValve heart valve through an artery in their leg. One hundred fifty (150) received the heart valve through a space between their ribs or an artery in their neck.

Patients were seen at:

  • 30 days
  • 6 months
  • 1 year

Yearly checkups will continue for 5 years.

The study results at 1 year showed:

The CoreValve procedure had an acceptable safety profile and was an effective alternative

to other options — medications or balloon valvuloplasty.

ADDITIONAL CLINICAL STUDIES

If you are interested, ask your doctor for more information on additional clinical studies.