Trial Outcomes & Findings for China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population (NCT NCT03314857)

NCT ID: NCT03314857

Last Updated: 2023-09-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 67 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2023-09-05

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. Six of the 67 patients enrolled were roll-in patients.

Participant milestones

Measure	Patients With SAPIEN XT THV Patients were implanted with the Edwards SAPIEN XT™ Transcatheter Heart Valve using the NovaFlex+ delivery system.
Overall Study STARTED	67
Overall Study Analysis Population	61
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Patients With SAPIEN XT THV Patients were implanted with the Edwards SAPIEN XT™ Transcatheter Heart Valve using the NovaFlex+ delivery system.
Overall Study Death	4
Overall Study Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Patients With SAPIEN XT THV n=61 Participants Patients were implanted with the Edwards SAPIEN XT™ Transcatheter Heart Valve using the NovaFlex+ delivery system.
Age, Continuous	77.9 years STANDARD_DEVIATION 5.44 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	61 Participants n=5 Participants
Region of Enrollment China	61 Participants n=5 Participants
STS Score	6.8 units on a scale STANDARD_DEVIATION 3.72 • n=5 Participants
NYHA Class Grouped Class I/II	5 Participants n=5 Participants
NYHA Class Grouped Class III/IV	56 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 XT THV n=61 Participants Patients were implanted with the Edwards SAPIEN XT™ Transcatheter Heart Valve using the NovaFlex+ delivery system.
All-cause Mortality	4 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 XT THV n=61 Participants Patients were implanted with the Edwards SAPIEN XT™ Transcatheter Heart Valve using the NovaFlex+ delivery system.
Cardiovascular Mortality	4 Participants

SECONDARY outcome

Timeframe: 30 days

Total number of participates with a stroke.

Outcome measures

Measure	Patients With SAPIEN XT THV n=61 Participants Patients were implanted with the Edwards SAPIEN XT™ Transcatheter Heart Valve using the NovaFlex+ delivery system.
Number of Participates With a Stroke	0 Participants

Adverse Events

Patients With SAPIEN XT THV

Serious events: 16 serious events

Other events: 53 other events

Deaths: 4 deaths

Serious adverse events

Measure	Patients With SAPIEN XT THV n=61 participants at risk Patients were implanted with the Edwards SAPIEN XT™ Transcatheter Heart Valve using the NovaFlex+ delivery system.
Cardiac disorders Acute coronary syndrome	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Cardiac disorders Atrial fibrillation	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Cardiac disorders Atrioventricular block complete	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Cardiac disorders Bundle branch block left	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Cardiac disorders Cardiac failure acute	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Cardiac disorders Cardio-respiratory arrest	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Cardiac disorders Myocardial rupture	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Cardiac disorders Sinus arrest	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Product Issues Device dislocation	3.3% 2/61 • Number of events 2 • 30-days All Adverse Events are site-reported.
Product Issues Device failure	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Metabolism and nutrition disorders Diabetes mellitus	1.6% 1/61 • Number of events 2 • 30-days All Adverse Events are site-reported.
Nervous system disorders Depressed level of consciousness	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Nervous system disorders Syncope	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
General disorders Device embolisation	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Infections and infestations Lung infection	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Injury, poisoning and procedural complications Vascular access site complication	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Respiratory, thoracic and mediastinal disorders Bronchial haemorrhage	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.
Vascular disorders Iliac artery perforation	1.6% 1/61 • Number of events 1 • 30-days All Adverse Events are site-reported.

Other adverse events

Measure	Patients With SAPIEN XT THV n=61 participants at risk Patients were implanted with the Edwards SAPIEN XT™ Transcatheter Heart Valve using the NovaFlex+ delivery system.
Cardiac disorders Bundle branch block left	18.0% 11/61 • Number of events 11 • 30-days All Adverse Events are site-reported.
Cardiac disorders Atrioventricular block first degree	8.2% 5/61 • Number of events 5 • 30-days All Adverse Events are site-reported.
Cardiac disorders Atrial fibrillation	6.6% 4/61 • Number of events 4 • 30-days All Adverse Events are site-reported.
Injury, poisoning and procedural complications Post procedural fever	16.4% 10/61 • Number of events 10 • 30-days All Adverse Events are site-reported.
Injury, poisoning and procedural complications Procedural haemorrhage	14.8% 9/61 • Number of events 9 • 30-days All Adverse Events are site-reported.
Injury, poisoning and procedural complications Vascular access site haemorrhage	8.2% 5/61 • Number of events 7 • 30-days All Adverse Events are site-reported.
Injury, poisoning and procedural complications Post procedural constipation	6.6% 4/61 • Number of events 4 • 30-days All Adverse Events are site-reported.
Investigations Troponin T increased	45.9% 28/61 • Number of events 28 • 30-days All Adverse Events are site-reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.6% 4/61 • Number of events 4 • 30-days All Adverse Events are site-reported.
Gastrointestinal disorders Constipation	9.8% 6/61 • Number of events 6 • 30-days All Adverse Events are site-reported.
General disorders Pyrexia	8.2% 5/61 • Number of events 5 • 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