Evolut PRO China Clinical Study

Study Overview
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Brief Summary
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Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve™ Evolut™ PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR).

Detailed Description
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This study is a prospective, single arm, multi-center, interventional, pre-market trial to obtain clinical data from Chinese implanting centers to support product registration of the Medtronic CoreValve™ Evolut™ PRO System (TAV, DCS and LS) with the National Medical Product Administration (NMPA) in China. Estimating 65 subjects with a maximum of up to 70 subjects in China with an attempted implant and followed the assessment with pre and post-procedure, discharge, 30 days(primary endpoint), 6months, 1 year, and annually through 5 years.

Official Title
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Medtronic CoreValve™ Evolut™ PRO System China Clinical Study

Conditions
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Severe, Symptomatic Aortic Stenosis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aortic valve area (AVA) < 1.0 cm2 (or indexed AVA <0.6 cm2/m2) OR mean gradient > 40 mmHg, OR max aortic velocity > 4.0 m/sec High risk for SAVR defined as STS-PROM score ≥ 8% AND ≤ 15%, OR documented Heart Team agreement of high risk for AVR due to frailty or comorbidities Symptoms of aortic stenosis and NYHA ≥ II Exclusion Criteria: Age is less than 65 years old Non-calcified aortic valve Bicuspid aortic valve with no raphe or 2 raphes (Sievers classification type 0 or type 2) Ascending aortic diameter > 4.5 cm

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 CoreValve™ Evolut™ PRO System<br>The system comprised of the following three components: CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (TAV) EnVeo™ PRO Delivery Catheter System (DCS) EnVeo™ PRO Loading System (LS) | Device: Medtronic CoreValve™ Evolut™ PRO System<br>* The system comprised of the following three components: CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (TAV) EnVeo™ PRO Delivery Catheter System (DCS) EnVeo™ PRO Loading System (LS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Percentage of participants with all-cause mortality, cardiovascular and non-cardiovascular mortality | 30 days | 
| Percentage (%) of evaluable echocardiograms with moderate or severe aortic regurgitation | Percentage (%) of evaluable echocardiograms with moderate or severe aortic regurgitation by transthoracic echocardiography (TTE) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of an VARC II combined composite | Incidence of an VARC II combined composite includes the following components: All-cause mortality All stroke (disabling and non-disabling) Life-threatening bleeding Acute kidney injury: stage 2 or 3 (including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR) | 30 days | 
| Event rates of the individual components of the VARC II composite | Event rate of the individual components listed in the outcome 3 | 30 days | 
| New permanent pacemaker rate | New permanent pacemaker rate | 30 days | 
| Device success rate | Device success rate: Percentage of participants with absence of procedural mortality, AND Percentage of participants with correct positioning of a single prosthetic heart valve into the proper anatomical location, AND Percentage of participants with 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 <3m/sec), AND absence of moderate or severe prosthetic valve regurgitation | Between 24 hours and 7 days post procedure | 
| Valve performance parameter - Mean aortic gradient | • Mean aortic gradient | 30 days | 
| Valve performance parameter - Effective orifice area | • Effective orifice area | 30 days | 
| Valve performance parameter -Degree of aortic regurgitation (transvalvular, paravalvular, total) | • Degree of aortic regurgitation (transvalvular, paravalvular, total) | 30 days |