Evolut PRO China Clinical Study

Not Applicable

Active, not recruiting

• Conditions: Severe, Symptomatic Aortic Stenosis
• Interventions: Device: Medtronic CoreValve™ Evolut™ PRO System

• Registration Number: NCT04982588
• Lead Sponsor: Medtronic Cardiovascular

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-07-08
• Study Start: 2021-07-17
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-07-29
• Primary Completion: 2023-03-17
• Results First Submitted: 2024-02-29
• Results First Submitted QC: 2024-11-18
• Results First Posted: 2024-11-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-30
• Study Completion: 2028-05-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medtronic CoreValve™ Evolut™ PRO System	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)

Primary Outcome Measures

Name	Time	Method
All-cause Mortality	30 days	All-cause mortality at 30 days
Percentage (%) of Subjects With Evaluable Echocardiograms With Moderate or Severe Aortic Regurgitation by Transthoracic Echocardiography (TTE)	30 days	Percentage (%) of Subjects with evaluable echocardiograms with moderate or severe aortic regurgitation by transthoracic echocardiography (TTE)

Secondary Outcome Measures

Name	Time	Method
Incidence of an VARC II Combined Composite	30 days	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)
Event Rates of the Individual Components of the VARC II Composite	30 days	Event rate of the individual components listed in the outcome
New Permanent Pacemaker Rate	30 days	New permanent pacemaker rate
Device Success Rate	Between 24 hours and 7 days post procedure	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
Valve Performance Parameter - Mean Aortic Gradient	30 days	Mean aortic gradient
Valve Performance Parameter - Effective Orifice Area	30 days	Effective orifice area
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total)	30 days	Degree of aortic regurgitation (transvalvular, paravalvular, total)

Trial Locations

Locations (4)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Chinese PLA General Hospital, Chinese PLA Medical School; 🇨🇳 Beijing, Beijing, China

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China