Evolut PRO China Clinical Study

Covidien

Status: Active, not recruiting

Conditions: Severe, Symptomatic Aortic Stenosis

Treatments: Device: Medtronic CoreValve™ Evolut™ PRO System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04982588

MDT18065EVR009

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 52 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Medtronic CoreValve™ Evolut™ PRO System

Experimental group

Description:

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)

Treatment:

Device: Medtronic CoreValve™ Evolut™ PRO System