Trial Outcomes & Findings for China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population (NCT NCT03466918)

NCT ID: NCT03466918

Last Updated: 2025-09-10

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: 30-days
• Results posted on: 2025-09-10

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 milestones

Measure	Patients With SAPIEN 3 THV Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
Overall Study STARTED	58
Overall Study Analysis Population	50
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Patients With SAPIEN 3 THV n=50 Participants Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
Age, Continuous	76.8 years STANDARD_DEVIATION 6.07 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	50 Participants n=5 Participants
Region of Enrollment China	50 Participants n=5 Participants
STS Score	6.0 units on a scale STANDARD_DEVIATION 2.77 • n=5 Participants
NYHA Class Grouped Class I/II	9 Participants n=5 Participants
NYHA Class Grouped Class III/IV	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30-days

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

Outcome measures

Measure	Patients With SAPIEN 3 THV n=50 Participants Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
All-cause Mortality	0 Participants

SECONDARY outcome

Timeframe: 30-days

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

Outcome measures

Measure	Patients With SAPIEN 3 THV n=50 Participants Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
Cardiovascular Mortality	0 Participants

SECONDARY outcome

Timeframe: 30-days

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

Outcome measures

Measure	Patients With SAPIEN 3 THV n=50 Participants Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
Non-Cardiovascular Mortality	0 Participants

SECONDARY outcome

Timeframe: 30-days

Total number of participates with a stroke.

Outcome measures

Measure	Patients With SAPIEN 3 THV n=50 Participants Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
Number of Participants With a Stroke	1 Participants

Adverse Events

Patients With SAPIEN 3 THV

Serious events: 13 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Measure	Patients With SAPIEN 3 THV n=50 participants at risk Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
Cardiac disorders Cardiac arrest	4.0% 2/50 • Number of events 2 • 30-days All Adverse Events are site-reported.
Cardiac disorders Atrioventricular block complete	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Cardiac disorders Cardiac failure	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Cardiac disorders Cardiac failure acute	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Cardiac disorders Coronary artery occlusion	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Cardiac disorders Ventricular flutter	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Cardiac disorders Ventricular tachycardia	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Injury, poisoning and procedural complications Femoral neck fracture	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Injury, poisoning and procedural complications Vascular access site occlusion	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Investigations Platelet count decreased	2.0% 1/50 • Number of events 2 • 30-days All Adverse Events are site-reported.
Nervous system disorders Dizziness	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Nervous system disorders Ischaemic stroke	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Blood and lymphatic system disorders Pancytopenia	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Infections and infestations Lung infection	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Metabolism and nutrition disorders Diabetes mellitus	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.
Vascular disorders Deep vein thrombosis	2.0% 1/50 • Number of events 1 • 30-days All Adverse Events are site-reported.

Other adverse events

Measure	Patients With SAPIEN 3 THV n=50 participants at risk Patients were implanted with the Edwards SAPIEN 3 Transcatheter Heart Valve using the Commander delivery system.
Investigations Fibrin D dimer increased	34.0% 17/50 • Number of events 17 • 30-days All Adverse Events are site-reported.
Investigations Troponin T increased	32.0% 16/50 • Number of events 16 • 30-days All Adverse Events are site-reported.
Investigations Troponin increased	18.0% 9/50 • Number of events 9 • 30-days All Adverse Events are site-reported.
Investigations Blood glucose increased	6.0% 3/50 • Number of events 3 • 30-days All Adverse Events are site-reported.
Injury, poisoning and procedural complications Procedural haemorrhage	24.0% 12/50 • Number of events 12 • 30-days All Adverse Events are site-reported.
Injury, poisoning and procedural complications Vascular access site haemorrhage	16.0% 8/50 • Number of events 9 • 30-days All Adverse Events are site-reported.
Injury, poisoning and procedural complications Post procedural fever	14.0% 7/50 • Number of events 7 • 30-days All Adverse Events are site-reported.
Injury, poisoning and procedural complications Post procedural constipation	6.0% 3/50 • Number of events 3 • 30-days All Adverse Events are site-reported.
Blood and lymphatic system disorders Thrombocytopenia	26.0% 13/50 • Number of events 13 • 30-days All Adverse Events are site-reported.
Blood and lymphatic system disorders Anaemia	8.0% 4/50 • Number of events 4 • 30-days All Adverse Events are site-reported.
Blood and lymphatic system disorders Leukocytosis	6.0% 3/50 • Number of events 3 • 30-days All Adverse Events are site-reported.
Cardiac disorders Bundle branch block left	14.0% 7/50 • Number of events 7 • 30-days All Adverse Events are site-reported.
Cardiac disorders Atrial fibrillation	8.0% 4/50 • Number of events 4 • 30-days All Adverse Events are site-reported.
Cardiac disorders Atrioventricular block first degree	6.0% 3/50 • Number of events 3 • 30-days All Adverse Events are site-reported.
General disorders Pyrexia	12.0% 6/50 • Number of events 6 • 30-days All Adverse Events are site-reported.
General disorders Oedema peripheral	8.0% 4/50 • Number of events 4 • 30-days All Adverse Events are site-reported.
Gastrointestinal disorders Constipation	8.0% 4/50 • Number of events 4 • 30-days All Adverse Events are site-reported.
Skin and subcutaneous tissue disorders Ecchymosis	6.0% 3/50 • Number of events 3 • 30-days All Adverse Events are site-reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.0% 3/50 • Number of events 3 • 30-days All Adverse Events are site-reported.
Respiratory, thoracic and mediastinal disorders Haemoptysis	6.0% 3/50 • Number of events 3 • 30-days All Adverse Events are site-reported.
Renal and urinary disorders Haematuria	6.0% 3/50 • Number of events 3 • 30-days All Adverse Events are site-reported.
Infections and infestations Lung infection	6.0% 3/50 • Number of events 3 • 30-days All Adverse Events are site-reported.

Additional Information

Director of Research

Edwards Lifesciences

Phone: 949-250-2500

Email: THV_CT.gov@edwards.com

Results disclosure agreements

• Principal investigator is a sponsor employee Without the Sponsor's prior written consent, the Principal Investigator shall not publish the clinical study results or any documents containing any Study information at any academic conferences or in any publications of any nature.
• Publication restrictions are in place

Restriction type: OTHER