Evolut™ EXPAND TAVR II Pivotal Trial

Launched by MEDTRONIC CARDIOVASCULAR · Nov 24, 2021

Keywords

ClinConnect Summary

The Evolut™ EXPAND TAVR II Pivotal Trial is studying a heart procedure called Transcatheter Aortic Valve Replacement (TAVR) to see if it is safe and effective for patients with moderate aortic valve stenosis (AS). Aortic valve stenosis is a condition where the heart's aortic valve becomes narrowed, making it harder for the heart to pump blood. This trial aims to gather important data to potentially expand the use of the Medtronic TAVR System for these patients.

To participate in this trial, individuals typically must be 65 years or older and have specific measurements showing moderate aortic stenosis, such as a certain valve area and blood flow speed. They should also have symptoms like shortness of breath during activities or a recent heart failure event. If eligible, participants can expect to undergo the TAVR procedure and will be monitored closely by their healthcare team throughout the study. This trial is currently recruiting participants, and anyone interested should discuss the details with their doctor to see if it’s a good fit for them.

Gender

ALL

Eligibility criteria

• 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 years
• • LVEF ≤ 20% by 2-D echo
• • Class I indication for cardiac surgery
• • Contraindication for placement of a bioprosthetic valve
• • Documented history of cardiac amyloidosis