Trial Outcomes & Findings for The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis (NCT NCT03471065)
NCT ID: NCT03471065
Last Updated: 2025-05-18
Results Overview
The number of patients with procedural success, defined as freedom from all of the following at exit from the procedure room: * Mortality * Conversion to surgery * Moderate or severe paravalvular regurgitation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Day 0
Results posted on
2025-05-18
Participant Flow
Participant milestones
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV: Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=100 Participants
SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV: Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
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|---|---|
|
Age, Continuous
|
83.5 years
STANDARD_DEVIATION 6.27 • n=100 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=100 Participants
|
|
Society of Thoracic Surgeons (STS) Score
|
3.6 units on a scale
STANDARD_DEVIATION 1.29 • n=100 Participants
|
|
New York Heart Association (NYHA) Class Grouped
Class I/II
|
56 Participants
n=100 Participants
|
|
New York Heart Association (NYHA) Class Grouped
Class III/IV
|
44 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Day 0The number of patients with procedural success, defined as freedom from all of the following at exit from the procedure room: * Mortality * Conversion to surgery * Moderate or severe paravalvular regurgitation
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=100 Participants
SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV: Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
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|---|---|
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Procedural Success
|
100 Participants
|
SECONDARY outcome
Timeframe: Discharge, expected to be within 1-5 days post-procedure]Number of patients with major vascular complications
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=100 Participants
SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV: Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
|
|---|---|
|
Major Vascular Complications
|
2 Participants
|
SECONDARY outcome
Timeframe: Discharge, expected to be within 1-5 days post-procedure]Number of patients with valve migration or embolization
Outcome measures
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=100 Participants
SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV: Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
|
|---|---|
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Valve Migration or Embolization
|
0 Participants
|
Adverse Events
Transcatheter Aortic Valve Replacement (TAVR)
Serious events: 28 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=100 participants at risk
SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV: Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
|
|---|---|
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Cardiac disorders
Atrioventricular block complete
|
7.0%
7/100 • Number of events 7 • 30 days
|
|
Cardiac disorders
Atrioventricular block first degree
|
2.0%
2/100 • Number of events 2 • 30 days
|
|
Cardiac disorders
Atrioventricular block second degree
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Cardiac disorders
Bundle branch block bilateral
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Cardiac disorders
Bundle branch block left
|
3.0%
3/100 • Number of events 3 • 30 days
|
|
Cardiac disorders
Sinus arrest
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Cardiac disorders
Ventricular asystole
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
General disorders
Prosthetic cardiac valve stenosis
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Infections and infestations
Enterococcal bacteraemia
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Infections and infestations
Pneumonia aspiration
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
Arterial injury
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
2.0%
2/100 • Number of events 2 • 30 days
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
3.0%
3/100 • Number of events 3 • 30 days
|
|
Injury, poisoning and procedural complications
Vascular access site pseudoaneurysm
|
2.0%
2/100 • Number of events 2 • 30 days
|
|
Nervous system disorders
Ischaemic stroke
|
3.0%
3/100 • Number of events 3 • 30 days
|
|
Nervous system disorders
Transient ischaemic attack
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Vascular disorders
Femoral artery dissection
|
2.0%
2/100 • Number of events 2 • 30 days
|
|
Vascular disorders
Femoral artery perforation
|
1.0%
1/100 • Number of events 1 • 30 days
|
|
Vascular disorders
Iliac artery perforation
|
1.0%
1/100 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Transcatheter Aortic Valve Replacement (TAVR)
n=100 participants at risk
SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV: Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
|
|---|---|
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Cardiac disorders
Bundle branch block left
|
8.0%
8/100 • Number of events 8 • 30 days
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
6.0%
6/100 • Number of events 6 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place