Vanderbilt Clinical Trials

Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

At least one of the following three options for aortic stenosis and/or the single option
for mitral regurgitation are determined from echocardiogram findings:

1. AVA or DI (Patients with either Aortic valve area (AVA) or Dimensionless Index (DI)
measured in their echo as well as at least one hemodynamic measure above the minimum
threshold)

a. Either: i. Aortic Valve Area ≤ 1.0 cm2 ii. Dimensionless Index ≤ 0.25 b. AND ANY
of i. Aortic Mean Gradient ≥ 15 mmHg ii. Aortic Peak Gradient ≥ 30 mmHg iii. Aortic
Jet Velocity ≥ 2.75 m/s

2. AVA + OTHER (Patients with AVA and at least 1 other echo measurement in their echo
above the threshold)

1. 1.0 cm2 < Aortic Valve Area ≤ 1.2 cm2

2. AND ANY of:

i. Aortic Mean Gradient ≥ 40 mmHg ii. Aortic Peak Gradient ≥ 64 mmHg iii. Aortic Jet
Velocity ≥ 4.0 m/s

3. POSSIBLE (Possible Aortic Stenosis but requires human review) a. Aortic Valve Area
is NULL OR >1.2 cm2 b. AND ANY of: i. Aortic Mean Gradient ≥ 40 mmHg ii. Aortic Peak
Gradient ≥ 64 mmHg iii. Aortic Jet Velocity ≥ 4.0 m/s OR a. EITHER i. Aortic Valve
Area ≤ 1.0 cm2 ii. Dimensionless Index ≤ 0.25 b. AND ALL are: i. Aortic Mean
Gradient < 15 mmHg ii. Aortic Peak Gradient < 30 mmHg iii. Aortic Peak Velocity <
2.75 m/s

ALERT Study Clinical Investigation Plan Version 2.1 page 12 of 54

Any patient flagged for "POSSIBLE" does not result in automatically alerting the
provider, instead a notification is sent to the Tempus research team for manual review in
conjunction with the site Principal Investigator (PI) and if requested by Tempus or site
PI, a Steering Committee member. If clinical confirmation is received for severe aortic
stenosis from the site PI, an alert is sent to the provider. 1. Mitral Regurgitation

a. Mention of severe mitral regurgitation or moderate- severe mitral regurgitation

Any patient mentioned with only moderate MR or a lesser severity will be excluded.

Exclusion Criteria:

1. Age < 18 years

2. Patient had evidence of a prior transcatheter or surgical repair or replacement of
the target valve

3. The echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon

4. Patient already has a scheduled clinic visit with a member of the MHT or a recent
(since the start of the study at that site ) clinic visit with the MHT, or a
scheduled transcatheter or surgical VI in the future.