Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Cardiovascular
Multi-center, international, prospective, randomized study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the Evolut PRO+ TAVR System, or Evolut FX System, and guideline-directed management (GDMT) or GDMT alone.
Age
65–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Age \< 65 years
LVEF ≤ 20% by 2-D echo
Class I indication for cardiac surgery
Contraindication for placement of a bioprosthetic valve
