Frontlight ResearchEarly access
Active, not recruitingNo phase
Evolut PRO China Clinical Study
Key facts
- Who runs it
- Medtronic Cardiovascular
- Where
- China4 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 52 people enrolled
- Started
- 17 Jul 2021
- Expected to end
- 15 May 2028
- Type of study
- Interventional
- Treatments tested
- Medtronic CoreValve™ Evolut™ PRO System
- Record updated
- 3 December 2025
Who can take part
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
The group in the trial
- Medtronic CoreValve™ Evolut™ PRO SystemTreatment being tested
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)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Medtronic CoreValve™ Evolut™ PRO System China Clinical Study
- Record updated
- 3 December 2025