Medtronic Evolut™ EXPAND TAVR I Feasibility Study

Study Overview
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Brief Summary
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The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.

Detailed Description
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Single-arm, descriptive, multi-center, international All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.

Official Title
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Medtronic Evolut™ EXPAND TAVR I Feasibility Study

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Medtronic Evolut™ PRO+ System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm^2, or aortic valve area index ≤ 0.6 cm^2/m^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec Subject denies symptoms attributable to aortic stenosis, including but not limited to: Dyspnea on rest or exertion Angina Syncope in the absence of another identifiable cause Fatigue Left Ventricular Ejection Fraction (LVEF) >50% Key Exclusion Criteria: Age <65 years Class I indication for cardiac surgery Bicuspid, unicuspid, or quadricuspid aortic valve In need of and suitable for coronary revascularization

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medtronic Evolut™ PRO+ System<br>All study subjects will be treated with the Medtronic Evolut™ PRO+ TAVR System. | Device: Medtronic Evolut™ PRO+ System<br>* TAVR treatment with Medtronic Evolut™ PRO+ System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause and cardiovascular mortality | Rate of all-cause and cardiovascular mortality | 30 days | 
| All-cause and cardiovascular mortality | Rate of all-cause and cardiovascular mortality | 6 months | 
| All stroke (disabling and non-disabling) | Rate of disabling and non-disabling stroke | 30 days | 
| All stroke (disabling and non-disabling) | Rate of disabling and non-disabling stroke | 6 months | 
| Myocardial infarction (periprocedural and spontaneous) | Rate of periprocedural and spontaneous myocardial infarction | 30 days | 
| Myocardial infarction (periprocedural and spontaneous) | Rate of periprocedural and spontaneous myocardial infarction | 6 months | 
| Acute kidney injury | Rate of acute kidney injury | 30 days | 
| Acute kidney injury | Rate of acute kidney injury | 6 months | 
| Major vascular complications | Rate of major vascular complications | 30 days | 
| Major vascular complications | Rate of major vascular complications | 6 months | 
| Life-threatening bleed | Rate of life-threatening (or disabling) bleed | 30 days | 
| Life-threatening bleed | Rate of life-threatening (or disabling) bleed | 6 months | 
| New permanent pacemaker implantation (PPI) | Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline) | 30 days | 
| New permanent pacemaker implantation (PPI) | Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline) | 6 months | 
| New intraventricular conduction delays | Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline) | 30 days | 
| New intraventricular conduction delays | Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline) | 6 months | 
| New-onset atrial fibrillation | Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline) | 30 days | 
| New-onset atrial fibrillation | Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline) | 6 months | 
| Valve-related dysfunction requiring repeat procedure | Rare of valve-related dysfunction requiring repeat procedure | 30 days | 
| Valve-related dysfunction requiring repeat procedure | Rare of valve-related dysfunction requiring repeat procedure | 6 months | 
| Device success (VARC-2) | The VARC-2 definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity <3 m/sec), and absence of moderate or severe prosthetic valve regurgitation | Through 5 years post-implant | 
| Cardiovascular and heart failure hospitalizations | Rate of cardiovascular and heart failure hospitalizations | 30 days | 
| Cardiovascular and heart failure hospitalizations | Rate of cardiovascular and heart failure hospitalizations | 6 months | 
| Heart failure events | Rate of heart failure events | 30 days | 
| Heart failure events | Rate of heart failure events | 6 months | 
| Hemodynamic performance metrics (mean aortic gradient) by Doppler echocardiography |  | Discharge (12 hours to 7 days post-procedure) | 
| Hemodynamic performance metrics (mean aortic gradient) by Doppler echocardiography |  | 30 days | 
| Hemodynamic performance metrics (mean aortic gradient) by Doppler echocardiography |  | 6 months | 
| Hemodynamic performance metrics (effective orifice area) by Doppler echocardiography |  | Discharge (12 hours to 7 days post-procedure) | 
| Hemodynamic performance metrics (effective orifice area) by Doppler echocardiography |  | 30 days | 
| Hemodynamic performance metrics (effective orifice area) by Doppler echocardiography |  | 6 months | 
| Hemodynamic performance metrics (degree of total, para, and transvalvular prosthetic regurgitation) by Doppler echocardiography |  | Discharge (12 hours to 7 days post-procedure) | 
| Hemodynamic performance metrics (degree of total, para, and transvalvular prosthetic regurgitation) by Doppler echocardiography |  | 30 days | 
| Hemodynamic performance metrics (degree of total, para, and transvalvular prosthetic regurgitation) by Doppler echocardiography |  | 6 months | 
| Hemodynamic performance metrics (incidence of moderate and severe patient-prosthesis mismatch) by Doppler echocardiography |  | Discharge (12 hours to 7 days post-procedure) | 
| Hemodynamic performance metrics (incidence of moderate and severe patient-prosthesis mismatch) by Doppler echocardiography |  | 30 days | 
| Hemodynamic performance metrics (incidence of moderate and severe patient-prosthesis mismatch) by Doppler echocardiography |  | 6 months | 
| Change from baseline in New York Heart Association (NYHA) functional classification |  | 30 days and 6 months | 
| Change from baseline in six-minute walk test (6MWT) |  | 6 months | 
| Change from baseline in health-related Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) | KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | 30 days and 6 months | 
| Change from baseline in left ventricular ejection fraction (LVEF) |  | 6 months | 
| Change from baseline in global longitudinal strain (GLS) |  | 6 months | 
| Change from baseline in left ventricular filling pressure (E:e') |  | 6 months | 
| Change from baseline in stroke volume index (SVI) |  | 6 months | 
| Change from baseline in NT-pro B-type natriuretic peptide (NT-proBNP) |  | 6 months |