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CompletedNCT03466918Updated Sep 10, 2025Results posted

China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population

An interventional study of SAPIEN 3 THV with the Commander delivery system in Aortic Stenosis, Symptomatic Aortic Stenosis and Aortic Regurgitation, sponsored by Edwards Lifesciences. Completed at 4 sites in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Edwards Lifesciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study summary

To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

Read the detailed description

Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system will be used for this study.

A maximum of 60 patients with symptomatic severe calcific aortic stenosis requiring transcatheter aortic valve implantation (TAVI), who are considered high risk for surgical valve replacement who received a SAPIEN 3 THV.

02

Conditions studied

  • Aortic Stenosis
  • Symptomatic Aortic Stenosis
  • Aortic Regurgitation

Keywords

  • TAVI
  • TAVR
  • CHINA
  • SAPIEN 3
  • High Risk
  • Transcatheter aortic valve implantation
  • Transcatheter aortic valve replacement
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects who are considered to be operable and high risk for surgical valve replacement: STS Score ≥ 8 and ≤ 15 or Logistic EuroSCORE ≥ 15 and ≤ 40. If STS score is below 8 and Logistic EuroSCORE is below 15, patients should have other clinical or anatomical risk factors that would be considered high risk for surgery and documented by the heart team.
  2. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: AVA \< 0.8 cm2, Indexed AVA \<0.5 cm2/m2, mean gradient > 40mmHg, or peak aortic jet velocity > 4.0m/sec.
  3. NYHA Functional Class II or greater.
  4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the EC of the respective clinical site.
  5. The study patient agrees to comply with all required postprocedure follow-up visits.

Exclusion criteria

Exclusion Criteria:

  1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
  2. Aortic valve is a congenital unicuspid or is non-calcified.
  3. Aortic valve is bicuspid and the patient is less than 60 years old, or the aortic valve is bicuspid with no raphe (Sievers classification type 0).
  4. Anomalous coronary artery that would interfere with proper placement of the valve.
  5. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Patients with SAPIEN 3 THV

    Patients will be treated with Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system

    Device: SAPIEN 3 THV with the Commander delivery system

Interventions

  • DeviceSAPIEN 3 THV with the Commander delivery system

    Edwards SAPIEN 3 Transcatheter Heart Valve is implanted using the Commander delivery system

05

What researchers measure

Primary outcomes

  1. All-cause Mortality

    All of the deaths that occurred in this population regardless of the cause.

    Time frame: 30-days

Secondary outcomes

  1. Cardiovascular Mortality

    All of the deaths that occurred in this population due to a cardiovascular issue.

    Time frame: 30-days

  2. Non-Cardiovascular Mortality

    All of the deaths that occurred in this population due to a non-cardiovascular issue.

    Time frame: 30-days

  3. Number of Participants With a Stroke

    Total number of participates with a stroke.

    Time frame: 30-days

06

Results

Posted Jul 15, 2020

Participant flow

Each study site was allowed up to two roll-in patients. Per the protocol, roll-in patients completed all study visits and procedures but were not part of the analysis. Eight of the 58 patients enrolled were roll-in patients.

Participant flow — Overall Study
MilestonePatients With SAPIEN 3 THV
Started58
Analysis population50
Completed58
Not completed0

Outcome measures

PrimaryAll-cause Mortality

All of the deaths that occurred in this population regardless of the cause.

Time frame:
30-days
Reported as:
Count of participants · Participants
All-cause Mortality
ParticipantsPatients With SAPIEN 3 THV
All-cause Mortality0
SecondaryCardiovascular Mortality

All of the deaths that occurred in this population due to a cardiovascular issue.

Time frame:
30-days
Reported as:
Count of participants · Participants
Cardiovascular Mortality
ParticipantsPatients With SAPIEN 3 THV
Cardiovascular Mortality0
SecondaryNon-Cardiovascular Mortality

All of the deaths that occurred in this population due to a non-cardiovascular issue.

Time frame:
30-days
Reported as:
Count of participants · Participants
Non-Cardiovascular Mortality
ParticipantsPatients With SAPIEN 3 THV
Non-Cardiovascular Mortality0
SecondaryNumber of Participants With a Stroke

Total number of participates with a stroke.

Time frame:
30-days
Reported as:
Count of participants · Participants
Number of Participants With a Stroke
ParticipantsPatients With SAPIEN 3 THV
Number of Participants With a Stroke1

Adverse events

Collected over 30-days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Patients With SAPIEN 3 THV0/50 (0%)13/50 (26%)48/50 (96%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventPatients With SAPIEN 3 THV
Cardiac arrestCardiac disorders2/50
Atrioventricular block completeCardiac disorders1/50
Cardiac failureCardiac disorders1/50
Cardiac failure acuteCardiac disorders1/50
Coronary artery occlusionCardiac disorders1/50
Ventricular flutterCardiac disorders1/50
Ventricular tachycardiaCardiac disorders1/50
Femoral neck fractureInjury, poisoning and procedural complications1/50
Vascular access site occlusionInjury, poisoning and procedural complications1/50
Vascular pseudoaneurysmInjury, poisoning and procedural complications1/50
Most frequent other events
Showing 10 of 22
Most frequent other events
EventPatients With SAPIEN 3 THV
Fibrin D dimer increasedInvestigations17/50
Troponin T increasedInvestigations16/50
ThrombocytopeniaBlood and lymphatic system disorders13/50
Procedural haemorrhageInjury, poisoning and procedural complications12/50
Troponin increasedInvestigations9/50
Vascular access site haemorrhageInjury, poisoning and procedural complications8/50
Post procedural feverInjury, poisoning and procedural complications7/50
Bundle branch block leftCardiac disorders7/50
PyrexiaGeneral disorders6/50
AnaemiaBlood and lymphatic system disorders4/50

Baseline characteristics

Age, Continuous
Age, Continuous(years)Patients With SAPIEN 3 THV
Mean76.8 ± 6.07
Sex: Female, Male
Sex: Female, Male(Participants)Patients With SAPIEN 3 THV
Female23
Male27
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Patients With SAPIEN 3 THV
Chinese50
Region of Enrollment
Region of Enrollment(Participants)Patients With SAPIEN 3 THV
China50
STS Score
STS Score(units on a scale)Patients With SAPIEN 3 THV
Mean6.0 ± 2.77
NYHA Class Grouped
NYHA Class Grouped(Participants)Patients With SAPIEN 3 THV
Class I/II9
Class III/IV41
07

Study locations

4 sites
  • Fuwai Hospital, CAMS&PUMC
    Beijing, China
  • WestChina Hospital, Sichuan University
    Chengdu, China
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
    Hangzhou, China
  • Zhongshan Hospital Fudan University
    Shanghai, China
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 22, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03466918
Lead sponsor
Edwards Lifesciences
Responsible party
Sponsor
First posted
Mar 15, 2018
Start date
May 23, 2018
Primary completion
Jul 3, 2019
Completion
Jun 19, 2024
Results posted
Jul 15, 2020
Last update
Sep 10, 2025

Study contacts

Prof Junbo GE
principal investigator · Zhongshan Hospital and Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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