Evolut™ EXPAND TAVR II Pivotal Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 650
- Locations
- 186
- Primary Endpoint
- 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.
Study Overview
Brief Summary
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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
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
Arms & Interventions
Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT)
Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, & guideline-directed management & therapy
Intervention: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT) (Device)
Clinical site determined guideline-directed management and therapy (GDMT) alone
Clinical site determined guideline-directed management and therapy (GDMT) alone
Outcomes
Primary Outcomes
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.
Time Frame: 30 days
Life threatening or fatal bleeding is defined as BARC Type 3 or 4 and acute kidney injury is defined as VARC-3 Stage IV.
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention.
Time Frame: 2 years
Secondary Outcomes
- All-cause mortality(2 years)
- Unplanned cardiovascular hospitalizations(2 years)
- Heart failure hospitalizations or events.(2 years)
- Composite of all-cause mortality and heart failure hospitalizations or events.(2 years)
- Days alive and free of unplanned cardiovascular hospitalizations(2 years)
- Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline)(1 year)
- Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations(2 years)