Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
Who can participate
Age range65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
o Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL:
* AVA \>1.0 cm² and \<1.5cm²; or
* AVA ≤ 1.0 cm² with AVAI \> 0.6cm²/m² if BMI \< 30 kg/m²: or
* AVA ≤ 1.0 cm² with AVAI \> 0.5cm²/m² if BMI ≥ 30 kg/m²:
and
* Max aortic velocity ≥ 3.0 m/sec. and \< 4.0 m/sec. or
* Mean aortic gradient ≥ 20mmHg and \< 40.0 mmHg
Any of the following at-risk features:
* Symptoms of AS, defined as:
* NYHA ≥ Class II, or
* Reduced functional capacity, defined as
* 6MWT \< 300 meters, or
* \< 85% of age-sex predicted METs on exercise tolerance testing (ETT)
* Documented heart failure event or hospitalization for heart failure within 1 calendar year prior to consent
* NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml), or
* Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or
* Elevated aortic valve calcium score (\>1200 AU for females and \> 2000 AU for males) as assessed by the MDCT core lab, or
* Any of the following by the qualifying TTE as assessed by the ECL:
* Global longitudinal strain ≤16% (absolute value), or
* E/e' ≥ 14.0 (average of medial and lateral velocities), or
* Diastolic dysfunction ≥ Grade II, or
* LVEF \< 60%
* Stroke Volume Index \< 35 ml/m²
* Anatomically suitable for transfemoral TAVR using the Medtronic Evolut PRO+ or Evolut FX system
* The subject and the treating physician agree the subject will return for all required follow-up visits
Key Exclusion Criteria:
* Age \< 65 year…
What they're measuring
1
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.
Timeframe: 30 days
2
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention.