Evolut PRO China Clinical Study

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-17

Study Completion Date

2028-05-15

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).

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Detailed Description

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The study is targeting 6 centers with a maximum of 8 centers in China and estimating 65 subjects with a maximum of up to 70 subjects with attempted implants including 50 subjects with an attempted implant in primary study population and the first two attempted subjects at each site for roll-in population. The subjects will follow the assessment with pre and post-procedure, discharge, 30 days(primary endpoint), 6 months, 1 year, and annually through 5 years.

Conditions

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Severe, Symptomatic Aortic Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medtronic CoreValve™ Evolut™ PRO System

The system comprised of the following three components:

1. CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (TAV)
2. EnVeo™ PRO Delivery Catheter System (DCS)
3. EnVeo™ PRO Loading System (LS)

Group Type EXPERIMENTAL

Medtronic CoreValve™ Evolut™ PRO System

Intervention Type DEVICE

The system comprised of the following three components:

1. CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (TAV)
2. EnVeo™ PRO Delivery Catheter System (DCS)
3. EnVeo™ PRO Loading System (LS)

Interventions

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Medtronic CoreValve™ Evolut™ PRO System

The system comprised of the following three components:

1. CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (TAV)
2. EnVeo™ PRO Delivery Catheter System (DCS)
3. EnVeo™ PRO Loading System (LS)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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
2. 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
3. Symptoms of aortic stenosis and NYHA ≥ II

Exclusion Criteria

1. Age is less than 65 years old
2. Non-calcified aortic valve
3. Bicuspid aortic valve with no raphe or 2 raphes (Sievers classification type 0 or type 2)
4. Ascending aortic diameter \> 4.5 cm

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No