Trial Outcomes & Findings for SAPIEN 3 Ultra EU PMS (NCT NCT04860752)
NCT ID: NCT04860752
Last Updated: 2025-07-29
Results Overview
Number of days in hospital after the procedure
Recruitment status
COMPLETED
Target enrollment
500 participants
Primary outcome timeframe
Discharge from hospital, expected to be within 1-5 days post-procedure
Results posted on
2025-07-29
Participant Flow
Participant milestones
| Measure |
Transcatheter Aortic Valve Implantation (TAVI)
Patients receive Transcatheter Aortic Valve Implantation (TAVI)
|
|---|---|
|
Overall Study
STARTED
|
500
|
|
Overall Study
COMPLETED
|
482
|
|
Overall Study
NOT COMPLETED
|
18
|
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 Implantation (TAVI)
n=500 Participants
Patients receive Transcatheter Aortic Valve Implantation (TAVI)
|
|---|---|
|
Age, Continuous
|
74.7 years
STANDARD_DEVIATION 4.11 • n=500 Participants
|
|
Sex: Female, Male
Female
|
217 Participants
n=500 Participants
|
|
Sex: Female, Male
Male
|
283 Participants
n=500 Participants
|
PRIMARY outcome
Timeframe: Discharge from hospital, expected to be within 1-5 days post-procedurePopulation: As treated - all patients enrolled in the trial
Number of days in hospital after the procedure
Outcome measures
| Measure |
Transcatheter Aortic Valve Implantation (TAVI)
n=500 Participants
Patients receive Transcatheter Aortic Valve Implantation (TAVI)
|
|---|---|
|
Length of Index Hospitalization
|
3.3 days
Standard Error 0.11
|
SECONDARY outcome
Timeframe: 1 yearPopulation: As treated - all patients enrolled in the trial
Number of patients who died
Outcome measures
| Measure |
Transcatheter Aortic Valve Implantation (TAVI)
n=500 Participants
Patients receive Transcatheter Aortic Valve Implantation (TAVI)
|
|---|---|
|
Death
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: As treated - all patients enrolled in the trial
Number of patients who had a stroke
Outcome measures
| Measure |
Transcatheter Aortic Valve Implantation (TAVI)
n=500 Participants
Patients receive Transcatheter Aortic Valve Implantation (TAVI)
|
|---|---|
|
Stroke
|
7 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: As treated - all patients enrolled in the trial who did not previously have a permanent pacemaker implanted
Number of patients who received a new permanent pacemaker
Outcome measures
| Measure |
Transcatheter Aortic Valve Implantation (TAVI)
n=474 Participants
Patients receive Transcatheter Aortic Valve Implantation (TAVI)
|
|---|---|
|
New Requirement for Permanent Pacemaker
|
51 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: As treated - all patients enrolled in the trial
Number of patients who required valve reintervention
Outcome measures
| Measure |
Transcatheter Aortic Valve Implantation (TAVI)
n=500 Participants
Patients receive Transcatheter Aortic Valve Implantation (TAVI)
|
|---|---|
|
Aortic Valve Reintervention
|
3 Participants
|
SECONDARY outcome
Timeframe: At discharge from hospital, expected to be within 1-5 days post-procedurePopulation: Patients implanted with study valve who received an echocardiogram at discharge
Number of patients who had moderate or greater aortic regurgitation
Outcome measures
| Measure |
Transcatheter Aortic Valve Implantation (TAVI)
n=399 Participants
Patients receive Transcatheter Aortic Valve Implantation (TAVI)
|
|---|---|
|
Aortic Regurgitation
|
2 Participants
|
SECONDARY outcome
Timeframe: At discharge from hospital, expected to be within 1-5 days post-procedurePopulation: Patients implanted with study valve who received an echocardiogram at discharge
Mean gradient (mmHg)
Outcome measures
| Measure |
Transcatheter Aortic Valve Implantation (TAVI)
n=413 Participants
Patients receive Transcatheter Aortic Valve Implantation (TAVI)
|
|---|---|
|
Mean Gradient
|
12.8 mmHg
Standard Error 0.24
|
SECONDARY outcome
Timeframe: At discharge from hospital, expected to be within 1-5 days post-procedurePopulation: Patients implanted with study valve who received an echocardiogram at discharge
Aortic valve area (cm2)
Outcome measures
| Measure |
Transcatheter Aortic Valve Implantation (TAVI)
n=273 Participants
Patients receive Transcatheter Aortic Valve Implantation (TAVI)
|
|---|---|
|
Effective Orifice Area
|
1.6 cm2
Standard Error 0.02
|
SECONDARY outcome
Timeframe: At discharge from hospital, expected to be within 1-5 days post-procedurePopulation: As treated - all patients enrolled in the trial
Number of patients who were discharged to home or self-care (routine discharge)
Outcome measures
| Measure |
Transcatheter Aortic Valve Implantation (TAVI)
n=500 Participants
Patients receive Transcatheter Aortic Valve Implantation (TAVI)
|
|---|---|
|
Discharge Location
|
436 participants
|
Adverse Events
Transcatheter Aortic Valve Implantation (TAVI)
Serious events: 157 serious events
Other events: 42 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Transcatheter Aortic Valve Implantation (TAVI)
n=500 participants at risk
Patients receive Transcatheter Aortic Valve Implantation (TAVI)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.40%
2/500 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute coronary syndrome
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Angina unstable
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
12/500 • Number of events 13 • 1 year
|
|
Cardiac disorders
Atrial flutter
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial tachycardia
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrioventricular block complete
|
5.4%
27/500 • Number of events 27 • 1 year
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.6%
8/500 • Number of events 8 • 1 year
|
|
Cardiac disorders
Atrioventricular block second degree
|
2.2%
11/500 • Number of events 11 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.40%
2/500 • Number of events 3 • 1 year
|
|
Cardiac disorders
Bundle branch block bilateral
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Bundle branch block left
|
3.0%
15/500 • Number of events 15 • 1 year
|
|
Cardiac disorders
Bundle branch block right
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
1.8%
9/500 • Number of events 15 • 1 year
|
|
Cardiac disorders
Cardiac tamponade
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiogenic shock
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery stenosis
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Mitral valve incompetence
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Paroxysmal atrioventricular block
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
0.80%
4/500 • Number of events 4 • 1 year
|
|
Cardiac disorders
Sinus node dysfunction
|
0.40%
2/500 • Number of events 2 • 1 year
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Tachycardia
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
General disorders
Adverse drug reaction
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
General disorders
Asthenia
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
General disorders
Death
|
0.40%
2/500 • Number of events 2 • 1 year
|
|
General disorders
Device embolisation
|
0.40%
2/500 • Number of events 2 • 1 year
|
|
General disorders
Prosthetic cardiac valve regurgitation
|
0.80%
4/500 • Number of events 4 • 1 year
|
|
General disorders
Prosthetic cardiac valve thrombosis
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Bile duct stone
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.20%
1/500 • Number of events 2 • 1 year
|
|
Hepatobiliary disorders
Hepatic failure
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Jaundice
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Immune system disorders
Anaphylactic reaction
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Bacterial infection
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Bronchitis
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Cholangitis infective
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
COVID-19
|
0.60%
3/500 • Number of events 3 • 1 year
|
|
Infections and infestations
COVID-19 pneumonia
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Cystitis
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Device related infection
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Enterococcal infection
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Influenza
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
1.0%
5/500 • Number of events 5 • 1 year
|
|
Infections and infestations
Pneumonia aspiration
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Postoperative wound infection
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Respiratory tract infection
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Staphylococcal infection
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Streptococcal sepsis
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.40%
2/500 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.60%
3/500 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Aortic annulus rupture
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
1.0%
5/500 • Number of events 5 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.40%
2/500 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
1.4%
7/500 • Number of events 8 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.60%
3/500 • Number of events 3 • 1 year
|
|
Investigations
Transvalvular pressure gradient increased
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.60%
3/500 • Number of events 3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.40%
2/500 • Number of events 2 • 1 year
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Nervous system disorders
Disturbance in attention
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Nervous system disorders
Ischaemic stroke
|
1.0%
5/500 • Number of events 5 • 1 year
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Nervous system disorders
Presyncope
|
0.40%
2/500 • Number of events 2 • 1 year
|
|
Nervous system disorders
Syncope
|
0.60%
3/500 • Number of events 3 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
1.0%
5/500 • Number of events 5 • 1 year
|
|
Product Issues
Device deployment issue
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Product Issues
Patient-device incompatibility
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Confusional state
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Delirium
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Depression suicidal
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Hypomania
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.40%
2/500 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
5/500 • Number of events 5 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Abdominal cavity drainage
|
0.20%
1/500 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Hip surgery
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Pancreaticoduodenectomy
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic disorder
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic dissection
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Vascular disorders
Haemorrhage
|
0.40%
2/500 • Number of events 8 • 1 year
|
|
Vascular disorders
Hypertension
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Vascular disorders
Iliac artery dissection
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.80%
4/500 • Number of events 5 • 1 year
|
|
Vascular disorders
Peripheral artery occlusion
|
0.60%
3/500 • Number of events 3 • 1 year
|
|
Vascular disorders
Peripheral artery stenosis
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Vascular disorders
Phlebitis
|
0.20%
1/500 • Number of events 1 • 1 year
|
|
Vascular disorders
Shock haemorrhagic
|
0.20%
1/500 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Transcatheter Aortic Valve Implantation (TAVI)
n=500 participants at risk
Patients receive Transcatheter Aortic Valve Implantation (TAVI)
|
|---|---|
|
Cardiac disorders
Bundle branch block left
|
8.4%
42/500 • Number of events 42 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place