Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, symptomatic AS. The primary objective is to demonstrate the safety and effectiveness of the Medtronic TAVR system (on the background of GDMT) is superior to GDMT alone.
EXPAND TAVR II
Evolut™ EXPAND TAVR II Pivotal Trial
Heart failure
All genders
65+
Recruiting now
Overview
Principal Investigator: Charles Resor, MD
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Charles Resor, MD
Study details
Inclusion Criteria
- Moderate AS, defined as follows by transthoracic echo (TTE) at rest:
o Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, and
o Mean aortic gradient ≥ 20.0 mmHg and < 40.0 mmHg, and
o AVA >1.0 cm2 and < 1.5 cm2 - NYHA class ≥ II and symptoms of AS, including but not limited to:
o Dyspnea at rest or on exertion
o Fatigue
o Angina
o Syncope in the absence of another identifiable cause
- LVEF > 20% by 2-D echo
Exclusion Criteria
- * 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
Study Requirements
Screening/Baseline: Clinical assessment, TTE, multi-detector computed tomography (MDCT), 12-lead ECG, simple spirometry, NT-proBNP (or BNP), CBC, creatine, coronary arteriography, 6MWT, quality of life assessments (KCCQ and EQ-5D) Index Treatment: Clinical assessment, TAVR procedure + GDMT or GDMT alone 30 days: Clinical assessment, TTE, 12-lead ECG, NT-proBNP (or BNP), KCCQ, EQ-5D 6 months: Clinical assessment, TTE, 12-lead ECG, NT-proBNP (or BNP), 6MWT, KCCQ, EQ-5D 1 year: Clinical assessment, TTE, 12-lead ECG, NT-proBNP (or BNP), 6MWT, KCCQ, EQ-5D 18 months: Clinical assessment 2 years: Clinical assessment, TTE, NT-proBNP (or BNP), 6MWT, KCCQ, EQ-5D 3 through 5 years: Clinical assessment, TTE, EQ-5D 6 through 10 Years: Clinical assessment, TTE (TAVR arm only)