Evolut* EXPAND TAVR II Pivotal Trial

Recruiting

• Conditions: Moderate aortic stenosis; 10046973

• Registration Number: NL-OMON53699
• Lead Sponsor: Medtronic Trading NL BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Please see pg 31 and 32 Key inclusion criteria
Prospective subjects must meet all the following inclusion criteria to be
eligible for randomization:
1. Moderate aortic stenosis by TTE as assessed by the ECL:
o AVA > 1.0 and < 1.5 cm2; or
• AVA <= 1.0 cm2 with AVAI > 0.6 cm2/m2 if BMI < 30 kg/m2; or
• AVA <= 1.0 cm2 with AVAI > 0.5 cm2/m2 if BMI C30 kg/m2
and
o Max aortic velocity >= 3.0 m/sec and < 4.0 m/sec or mean aortic gradient >=
20.0 mmHg and < 40.0 mmHg

Subjects with low flow (SVI < 35 ml/m)2 and reduced LVEF (<50%), AVA <= 1.0 cm2,
and max aortic velocity >= 3.0 m/sec and < 4.0 m/sec OR mean gradient >= 20 mmHg
and < 40 mmHg can be included if low dose dobutamine stress echo (DSE)
demonstrates all the following:
- SVI >= 35 ml/m2, and
- AVA > 1.0 cm2 and < 1.5 cm2, and
- Mean aortic gradient >= 20.0 mmHg and < 40.0 mmHg OR max aortic velocity >= 3.0
m/sec and < 4.0 m/sec
Subjects with normal flow (SVI >= 35 ml/m)2and preserved LVEF (>= 50%), AVA <= 1.0
cm2 and max aortic velocity >= 3.0 m/sec and < 4.0 m/sec OR mean gradient >= 20
mmHg and < 40 mmHg can be included if aortic valve calcium score is < 1200 AU
for females and < 2000 AU for males.

2.(3) Listed in the CIP version F_18Sept2023 In the Symptoms of AS, defined as:
• NYHA > Class II, or
• Reduced functional capacity , defined as
o 6MWT < 300 meters118, 119, or
o < 85% of age-sex predicted metabolic equivalents (MET) on exercise tolerance
testing (ETT)109
3. Any of the following:
• Documented heart failure event or hospitalization for heart failure within 1
calendar year prior to consent, or
• 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 or > 2000 AU for
males) as assessed by the MDCT core lab, or
• Any of the following on the qualifying TTE as assessed by the ECL:
o Global longitudinal strain (GLS) <= 16.0% (absolute value), or
o E/e* >= 14.0 (average of medial and lateral velocities), or
o Diastolic dysfunction > Grade II
o LVEF < 60%, or
o Stroke Volume Index < 35 ml/m2
4. Anatomically suitable for transfemoral TAVR using the Medtronic Evolut PRO+
or Evolut FX system
5. The subject and treating physician agree the subject will return for all
required follow-up visits

Exclusion Criteria

Please see pg 32 and 33 Key exclusion criteria: * If any of the following
exclusion criteria are present, the prospective subject is not eligible for
randomization:
1. Age < 65 years
2. LVEF < 20% by 2-D echo
3. Class I indication for cardiac surgery
4. Contraindication for placement of a bioprosthetic valve
5. Documented history of cardiac amyloidosis
6. A known hypersensitivity or contraindication to any of the following that
cannot be adequately pre-medicated:
• Aspirin, heparin, or bivalirudin
• Ticlopidine and clopidogrel
• Nitinol (titanium or nickel)
• Gold
• Contrast media
7. Blood dyscrasias as defined: leukopenia (WBC < 1000 cells/mm3),
thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding
diathesis or coagulopathy, or hypercoagulable states
8. Ongoing sepsis, including active endocarditis
9. Frailty syndrome per Heart Valve Team assessment
10. Coronary revascularization (percutaneous coronary intervention or coronary
artery bypass graft) within 30 days prior to randomization
11. In need of and suitable for coronary revascularization per Heart Valve Team
12. Chronic obstructive pulmonary disease (GOLD stage 3 or higher)
13. Symptomatic carotid or vertebral artery disease or successful treatment of
carotid stenosis within 70 days of consent
14. Cardiogenic shock manifested by low cardiac output, vasopressor dependence,
or mechanical hemodynamic support
15. Placement of cardiac resynchronization device within 90 days of consent
16. Recent (within 60 days of consent) cerebrovascular accident (CVA) or
transient ischemic attack (TIA)
17. Child-Pugh class C liver cirrhosis
18. Gastrointestinal (GI) bleeding that would preclude anticoagulation
19. Severe dementia (resulting in either inability to provide informed consent
for the trial/procedure, prevents independent lifestyle outside of a chronic
care facility, or will fundamentally complicate rehabilitation from the
procedure or compliance with follow-up visits)
20. Estimated life expectancy of less than 24 months due to associated
non-cardiac co-morbid conditions
21. Other medical, social, or psychological conditions that in the opinion of
the investigator precludes the subject from appropriate consent or adherence to
the protocol required follow-up exams
22. Currently participating in an investigational drug or another device trial
or study (excluding registries)
23. Evidence of an acute myocardial infarction <= 30 days prior to consent
24. Advanced renal impairment (defined as GFR < 30 mL/min) or need for renal
replacement therapy
25. Need for emergency surgery for any reason
26. Subject is pregnant or breast feeding
27. Subject is less than legal age of consent, legally incompetent, unable to
provide his/her own informed consent, or otherwise vulnerable as defined in
Section *6.2.
Anatomical exclusion criteria:
28. Congenital unicuspid valve
29. Sievers Type 0 or Type 2 bicuspid aortic valve
30. Sievers Type 1 bicuspid aortic valve with ascending aorta diameter > 4.5 cm
31. Not anatomically suited for transfemoral TAVR with the trial device
32. Absence of calcified aortic valve
33. Severe LVOT calcification
34. Pre-existing prosthetic aortic valve
35. Severe mitral regurgitation by TTE as assessed by the Echo Core Lab
36. Severe tricuspid regurgitation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary safety objective is to demonstrate that the composite rate of<br /><br>all-cause mortality, all stroke, life-threatening or fatal bleeding (BARC Type<br /><br>3 or 4), acute kidney injury (VARC 3 - Stage IV), hospitalization due to device<br /><br>or procedure-related complication, or valve dysfunction requiring<br /><br>re-intervention at 30 days in the device arm is less than the performance goal.<br /><br>The primary effectiveness objective is to demonstrate the Medtronic TAVR system<br /><br>on the background of GDMT is superior to GDMT alone in the composite rate of<br /><br>all-cause mortality, heart failure hospitalization or event, or medical<br /><br>instability leading to aortic valve replacement or re-intervention at 2 years.<br /><br><br /><br>The primary effectiveness endpoint is defined as the composite of all-cause<br /><br>mortality, heart failure hospitalization or event, or medical instability<br /><br>leading to aortic valve replacement or re-intervention at 2 years.</p><br>