Evolut EXPAND TAVR II Pivotal Trial
- Conditions
- Moderate, symptomatic aortic stenosis
- Registration Number
- JPRN-jRCT2032220015
- Lead Sponsor
- Shiotani Takuya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 650
Moderate AS, defined as follows by transthoracic ech - (TTE) at rest:
- Max aortic velocity >= 3.0 m/sec and < 4.0 m/sec, and
- Mean aortic gradient >= 20.0 mmHg and < 40.0 mmHg, and
- AVA >1.0 cm2 and < 1.5 cm2
- NYHA class >= II and symptoms of AS, including but not limited to:
- Dyspnea at rest or on exertion
- Fatigue
- Angina
- Syncope in the absence of another identifiable cause
- LVEF > 20% by 2-D ech -
- Any of the following
- HF event or hospitalization within 1 calendar year prior t - qualifying ech -
- NT proBNP >= 600 pg/ml (or BNP 80 pg/ml) measured within 6 months prior t - or within 2 weeks after qualifying echo,
- Global longitudinal strain =<15.0% (absolute value) at qualifying echo, or
- E/e (average of medial and lateral velocities) >= 14.0 at qualifying echo
- Age < 65 years
- Class I indication for cardiac surgery
- Sievers Type 0 or Type 2 bicuspid aortic valve or Sievers Type 1 bicuspid aortic valve with ascending aorta diameter > 4.5 cm
- Not anatomically suitable for transfemoral TAVR
- In need of and suitable for coronary revascularization per Heart Valve Team
- Documented history of cardiac amyloidosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Safety: Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding (BARC Type 3 or 4), acute kidney injury (VARC-3 Stage IV), hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention at 30 days<br>- Effectiveness: Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention at 2 years
- Secondary Outcome Measures
Name Time Method - Proportion of subjects alive and with moderately improved quality of life (>= 10 points in KCCQ summary score from baseline) at 1 year<br>- Composite of all-cause mortality and heart failure hospitalizations or events at 2 years<br>- Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations (inclusive of all aortic valve replacement (AVR)) at 2 years<br>- Heart failure hospitalizations or events at 2 years<br>- All-cause mortality at 2 Years<br>- Unplanned cardiovascular hospitalizations at 2 years<br>- Days alive and free of unplanned cardiovascular hospitalizations (inclusive of all AVR) at 2 years