TAVR for Aortic Stenosis

N/A

Recruiting

Led By Josep Rodes-Cabau, MD

Research Sponsored by Medtronic Cardiovascular

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate AS, defined by transthoracic echo (TTE) as assessed by the ECL: AVA >1.0 cm² and < 1.5 cm² and Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, OR mean aortic gradient ≥ 20.0 mmHg and < 40.0 mmHg

Be older than 65 years old

Must not have

Documented history of cardiac amyloidosis

Not anatomically suitable for transfemoral TAVR with the trial device

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether the Medtronic TAVR System is safe and effective for patients with moderate, symptomatic aortic stenosis.

Who is the study for?

This trial is for adults over 65 with moderate, symptomatic aortic stenosis (AS) who have specific heart function measurements and are suitable for the Medtronic TAVR System via transfemoral access. Excluded are those needing cardiac surgery, with certain types of bicuspid aortic valves or severe heart issues like low ejection fraction or cardiac amyloidosis.

What is being tested?

The trial tests the safety and effectiveness of two Medtronic TAVR systems in expanding treatment to patients with moderate AS. Participants will receive either the Evolut PRO+ or FX system along with standard heart management therapies.

What are the potential side effects?

While not explicitly listed here, typical side effects from procedures like TAVR can include bleeding, blood vessel complications, irregular heartbeats, stroke, kidney injury, and sometimes death.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart valve is moderately narrowed.

Exclusion Criteria

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

Select...

I have been diagnosed with cardiac amyloidosis.

Select...

My body is not suitable for a specific heart valve replacement through the leg.

Select...

I need heart surgery as recommended by my doctor.

Select...

I am younger than 65 years old.

Select...

My aortic valve is abnormal, either Type 0, Type 2, or Type 1 with a large ascending aorta.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention.