Severe, Symptomatic Aortic StenosisNCT04982588

Evolut PRO China Clinical Study

A study testing Medtronic CoreValve™ Evolut™ PRO System in people with Severe, Symptomatic Aortic Stenosis, run by Medtronic Cardiovascular at 4 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Severe, Symptomatic Aortic Stenosis
What is being tested?: Medtronic CoreValve™ Evolut™ PRO System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 4 sitesChina
Study dates: 17 Jul 2021to 15 May 2028
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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 join

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

Trial locations and contacts

4 sites in 1 country.

China4 sites

Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Chinese PLA General Hospital, Chinese PLA Medical School
Beijing, Beijing Municipality, 100000
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: Medtronic CoreValve™ Evolut™ PRO System China Clinical Study

Read the 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.

Conditions: Severe, Symptomatic Aortic Stenosis
Being tested: Medtronic CoreValve™ Evolut™ PRO System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medtronic CoreValve™ Evolut™ PRO SystemDevice
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)

Study groups in NCT04982588
Study group	Role	What they receive
Medtronic CoreValve™ Evolut™ PRO System	Experimental	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) Receives: Device: Medtronic CoreValve™ Evolut™ PRO System

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 202115 May 2028

First posted29 Jul 2021
Study start17 Jul 2021
Primary completion17 Mar 2023
Study completion15 May 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Severe, Symptomatic Aortic StenosisStudies of the same condition, open and under way.
More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04982588
Sponsor's protocol ID: MDT18065EVR009
Status last verified: Nov 2025
First submitted: 8 Jul 2021
Last updated: 3 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Active, not recruiting
DurAVR™ THV EU-EFS
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
Enrolling by invitation
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
Aortic Valve Stenosis, Heart Valve Diseases
Not yet recruiting
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
Aortic Stenosis Senile, Aortic Stenosis Symptomatic
Recruiting
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
Aortic Stenosis

All Severe, Symptomatic Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medtronic CoreValve™ Evolut™ PRO System China Clinical Study
ClinicalTrials.gov ID: NCT04982588
Acronym / sponsor ID: MDT18065EVR009
Conditions: Severe, Symptomatic Aortic Stenosis
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 52 participants (actual)
Lead sponsor: Medtronic CardiovascularIndustry (pharma, biotech, devices)
Study start: 17 Jul 2021 (actual)
Primary completion: 17 Mar 2023 (actual)
Study completion: 15 May 2028 (estimated)
First posted: 29 Jul 2021 (actual)
Results: Posted 29 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Medtronic CoreValve™ Evolut™ PRO System	Experimental	Device: Medtronic CoreValve™ Evolut™ PRO SystemThe 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)

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medtronic CoreValve™ Evolut™ PRO SystemThe 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)	Device	Medtronic CoreValve™ Evolut™ PRO System

Primary outcome

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

7 secondary outcomes

Incidence of an VARC II Combined Composite
Time frame: 30 days
Event Rates of the Individual Components of the VARC II Composite
Time frame: 30 days
New Permanent Pacemaker Rate
Time frame: 30 days
Device Success Rate
Time frame: Between 24 hours and 7 days post procedure
Valve Performance Parameter - Mean Aortic Gradient
Time frame: 30 days
Valve Performance Parameter - Effective Orifice Area
Time frame: 30 days
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total)
Time frame: 30 days

Results and safety

Results posted to the registry on 29 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Medtronic CoreValve™ Evolut™ PRO System	52	50

Primary outcome: All-cause Mortality

Time frame: 30 days. Number. Unit: Percent of Participants (K-M Rate)

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n = 50
Value	0.0

Population analysed: Number of attempted implant population

Primary outcome: Percentage (%) of Subjects With Evaluable Echocardiograms With Moderate or Severe Aortic Regurgitation by Transthoracic Echocardiography (TTE)

Time frame: 30 days. Number (95% Confidence Interval). Unit: Percentage (%) of participants

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n = 45
Value	2.2 (0.1 to 11.8)

Population analysed: Number of subjects with evaluable aortic regurgitation from echo core lab

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: Medtronic CoreValve™ Evolut™ PRO System	28 of 50 (56%)	39 of 50 (78%)	5 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Severe, Symptomatic Aortic Stenosis

RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Active, not recruiting
DurAVR™ THV EU-EFS
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
Enrolling by invitation
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
Aortic Valve Stenosis, Heart Valve Diseases
Not yet recruiting
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
Aortic Stenosis Senile, Aortic Stenosis Symptomatic
Recruiting
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
Aortic Stenosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jianan Wang, MD principal investigator

Second Affiliated Hospital, Zhejiang University, School of Medicine

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Medtronic CoreValve™ Evolut™ PRO System in people with Severe, Symptomatic Aortic Stenosis, run by Medtronic Cardiovascular at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04982588.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.