Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Heart Team consensus patient has < 3% predicted risk of mortality at 30 days
for SAVR
* Severe aortic stenosis, defined as :
* Symptomatic aortic stenosis
Aortic valve area <= 1.0 cm2 (or aortic valve area index of <= 0.6 cm2/m2), OR
mean
gradient >= 40 mmHg, OR maximal aortic valve velocity >= 4.0 m/sec by
transthoracic echocardiography
* Asymptomatic aortic stenosis:
- Very severe aortic stenosis with an aortic valve area of <=1.0 cm2 (or aortic
valve area index of <=0.6 cm2/m2), AND maximal aortic velocity >= 5.0 m/sec,
or mean gradient >= 60 mmHg by transthoracic echocardiography, OR
- Aortic valve area of <=1.0 cm2 (or aortic valve area index of <=0.6 cm2/m2), AND
a mean gradient >= 40 mmHg, or maximal aortic valve velocity >= 4.0 m/sec by
transthoracic echocardiography, AND an exercise tolerance test that
demonstrates a limited exercise capacity, abnormal BP response, or
arrhythmia OR
- Aortic valve area of <= 1.0 cm2 (or aortic valve area index of <= 0.6 cm2/m2),
AND mean gradient >= 40 mmHg, or maximal aortic valve velocity >= 4.0 m/sec
by transthoracic echocardiography, AND a left ventricular ejection fraction <
50%.
* Indicated for SAVR with a bioprosthesis

Exclusion Criteria

Bicuspid aortic valve identified by echocardiography, MDCT, or Magnetic
Resonance
Imaging
Significant ascending aortopathy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>All-cause mortality or disabling stroke at 2 years</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety<br /><br>1. Composite of death, disabling stroke, life-threatening bleed, major vascular<br /><br>complication, or AKI (II or III) at 30 days<br /><br>2. New permanent pacemaker implantation at 30 days<br /><br>3. Prosthetic valve endocarditis at one year<br /><br>4. Prosthetic valve thrombosis at one year<br /><br>5. All stroke (disabling and non-disabling) at one year<br /><br>6. Life-threatening bleed at one year<br /><br>7. Valve-related dysfunction requiring repeat procedure at one year<br /><br>Effectiveness<br /><br>1. Valve-related dysfunction (moderate or severe stenosis or regurgitation) at<br /><br>one year<br /><br>2. Quality of Life as assessed by Kansas City Cardiomyopathy (KCCQ) at one year<br /><br>3. Repeat hospitalization for aortic valve disease at one year</p><br>