Trial Outcomes & Findings for REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System (NCT NCT01627691)
NCT ID: NCT01627691
Last Updated: 2020-05-12
Results Overview
Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
30 days
Results posted on
2020-05-12
Participant Flow
Participant milestones
| Measure |
REPRISE II and Extension Overall
Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.
Lotus Valve System: - bioprosthetic bovine pericardial aortic valve
\- delivery system
|
|---|---|
|
Overall Study
STARTED
|
250
|
|
Overall Study
Primary Endpoint (30days)
|
239
|
|
Overall Study
COMPLETED
|
232
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
REPRISE II and Extension Overall
Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.
Lotus Valve System: - bioprosthetic bovine pericardial aortic valve
\- delivery system
|
|---|---|
|
Overall Study
Death
|
11
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Missed the visit
|
3
|
Baseline Characteristics
REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System
Baseline characteristics by cohort
| Measure |
REPRISE II and Extension Overall
n=250 Participants
Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.
Lotus Valve System: - bioprosthetic bovine pericardial aortic valve
\- delivery system
|
|---|---|
|
Age, Continuous
|
84.0 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
250 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
74 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
171 Participants
n=5 Participants
|
|
EuroSCORE
|
6.4 percent predicted mortality
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
STS Score
|
6.5 units on a scale
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
NYHA Functional Class
Grade I
|
0 Participants
n=5 Participants
|
|
NYHA Functional Class
Grade II
|
57 Participants
n=5 Participants
|
|
NYHA Functional Class
Grade III
|
166 Participants
n=5 Participants
|
|
NYHA Functional Class
Grade IV
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: As specified, this endpoint was evaluated using data from the first 120 patients enrolled in the study
Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.
Outcome measures
| Measure |
REPRISE II and Extension Overall
n=120 Participants
Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.
Lotus Valve System: - bioprosthetic bovine pericardial aortic valve
\- delivery system
|
|---|---|
|
Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure
|
11.45 mmHG
Standard Deviation 5.20
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Mortality at 30 days from all patients enrolled in the study (ITT population): the proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure
Mortality at 30 days from all patients enrolled in the study (ITT population): the proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure
Outcome measures
| Measure |
REPRISE II and Extension Overall
n=249 Participants
Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.
Lotus Valve System: - bioprosthetic bovine pericardial aortic valve
\- delivery system
|
|---|---|
|
Primary Safety Endpoint: All-cause Mortality at 30 Days Post Implant Procedure
|
11 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Patients with an echocardiography available from the 30-day follow-up visit and analyzable by the Core Lab
Effective orifice area measured by echocardiography at 30 days and assessed by an independent core laboratory (ITT population)
Outcome measures
| Measure |
REPRISE II and Extension Overall
n=170 Participants
Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.
Lotus Valve System: - bioprosthetic bovine pericardial aortic valve
\- delivery system
|
|---|---|
|
Effective Orifice Area
|
1.73 square centimeter
Interval 1.66 to 1.79
|
SECONDARY outcome
Timeframe: Post-procedurePopulation: ITT population
Successful vascular access, delivery and deployment of the Lotus Valve System and successful retrieval of the delivery system as reported from site
Outcome measures
| Measure |
REPRISE II and Extension Overall
n=250 Participants
Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.
Lotus Valve System: - bioprosthetic bovine pericardial aortic valve
\- delivery system
|
|---|---|
|
Device Performance Endpoint: Successful Vascular Access
|
247 Participants
|
SECONDARY outcome
Timeframe: Post-procedurePopulation: Number of participants for whom a retrieval of the valve was attempted
Successful retrieval (complete resheathing of the Lotus valve in the catheter and removal from the body) of the Lotus Valve System if retrieval is attempted, as reported from site
Outcome measures
| Measure |
REPRISE II and Extension Overall
n=13 Participants
Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.
Lotus Valve System: - bioprosthetic bovine pericardial aortic valve
\- delivery system
|
|---|---|
|
Device Performance Endpoint: Successful Retrieval
|
12 Participants
|
SECONDARY outcome
Timeframe: Post-procedurePopulation: Number of participants for whom a repositioning of the valve was attempted
Successful repositioning (partial or complete resheathing of the Lotus Valve in the catheter and redeployment in a more accurate position within the aortic valve annulus) of the Lotus Valve System if repositioning is attempted for the last valve attempted, as reported from site
Outcome measures
| Measure |
REPRISE II and Extension Overall
n=85 Participants
Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.
Lotus Valve System: - bioprosthetic bovine pericardial aortic valve
\- delivery system
|
|---|---|
|
Device Performance Endpoint: Successful Repositioning
|
85 Participants
|
SECONDARY outcome
Timeframe: Post-procedurePopulation: Number of patients who had an echocardiography available post-procedure for the Core Lab to measure the performance of the prosthetic heart valve as described above
Absence of procedural mortality as reported from site AND Correct positioning of a single prosthetic heart valve into the proper anatomical location as reported from site AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, AND no moderate or severe prosthetic valve regurgitation as measured from an independent core lab on the post-procedure echocardiography)
Outcome measures
| Measure |
REPRISE II and Extension Overall
n=175 Participants
Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.
Lotus Valve System: - bioprosthetic bovine pericardial aortic valve
\- delivery system
|
|---|---|
|
Device Success According to the Valve Academic Research Consortium (VARC)
|
96 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Patients with echocardiography available from the 30-day follow-up visit and analyzable from the Core Lab for those measurements
Grade of paravalvular aortic valve regurgitation at 30 days as measured by echocardiography and assessed by an independent core laboratory
Outcome measures
| Measure |
REPRISE II and Extension Overall
n=210 Participants
Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.
Lotus Valve System: - bioprosthetic bovine pericardial aortic valve
\- delivery system
|
|---|---|
|
Grade of Aortic Valve Regurgitation
Severity not evaluable
|
1 Participants
|
|
Grade of Aortic Valve Regurgitation
None
|
159 Participants
|
|
Grade of Aortic Valve Regurgitation
Trace/Trivial
|
18 Participants
|
|
Grade of Aortic Valve Regurgitation
Mild
|
31 Participants
|
|
Grade of Aortic Valve Regurgitation
Mild-moderate
|
0 Participants
|
|
Grade of Aortic Valve Regurgitation
Moderate
|
1 Participants
|
|
Grade of Aortic Valve Regurgitation
Moderate-Severe
|
0 Participants
|
|
Grade of Aortic Valve Regurgitation
Severe
|
0 Participants
|
Adverse Events
REPRISE II and Extension Overall
Serious events: 152 serious events
Other events: 157 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
REPRISE II and Extension Overall
n=250 participants at risk
Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.
Lotus Valve System: - bioprosthetic bovine pericardial aortic valve
\- delivery system
|
|---|---|
|
Cardiac disorders
Total
|
38.8%
97/250 • Number of events 123 • Primary Endpoint (30days)
|
|
Cardiac disorders
Atrioventricular block complete
|
18.8%
47/250 • Number of events 47 • Primary Endpoint (30days)
|
|
Cardiac disorders
Atrial fibrillation
|
2.8%
7/250 • Number of events 7 • Primary Endpoint (30days)
|
|
Cardiac disorders
Bundle branch block left
|
2.8%
7/250 • Number of events 7 • Primary Endpoint (30days)
|
|
Cardiac disorders
Atrioventricular block
|
2.4%
6/250 • Number of events 6 • Primary Endpoint (30days)
|
|
Cardiac disorders
Cardiac tamponade
|
2.4%
6/250 • Number of events 6 • Primary Endpoint (30days)
|
|
Cardiac disorders
Cardiac arrest
|
2.0%
5/250 • Number of events 5 • Primary Endpoint (30days)
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.6%
4/250 • Number of events 4 • Primary Endpoint (30days)
|
|
Cardiac disorders
Cardiac failure
|
1.6%
4/250 • Number of events 4 • Primary Endpoint (30days)
|
|
Cardiac disorders
Cardiac failure congestive
|
1.6%
4/250 • Number of events 4 • Primary Endpoint (30days)
|
|
Cardiac disorders
Pericardial effusion
|
1.6%
4/250 • Number of events 4 • Primary Endpoint (30days)
|
|
Cardiac disorders
Atrioventricular block second degree
|
1.2%
3/250 • Number of events 3 • Primary Endpoint (30days)
|
|
Cardiac disorders
Bradycardia
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
Cardiac disorders
Left ventricular failure
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
Cardiac disorders
Myocardial infarction
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
Cardiac disorders
Sick sinus syndrome
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
Cardiac disorders
Aortic valve incompetence
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Atrial flutter
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Cardiac perforation
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Conduction disorder
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Coronary ostial stenosis
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Electromechanical dissociation
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Mitral valve incompetence
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Right ventricular failure
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Sinus arrest
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Trifascicular block
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Ventricle rupture
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Ventricular dysfunction
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Cardiac disorders
Ventricular fibrillation
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
General disorders
Total
|
10.4%
26/250 • Number of events 28 • Primary Endpoint (30days)
|
|
General disorders
Catheter site haematoma
|
4.8%
12/250 • Number of events 12 • Primary Endpoint (30days)
|
|
General disorders
Catheter site haemorrhage
|
2.8%
7/250 • Number of events 7 • Primary Endpoint (30days)
|
|
General disorders
Pyrexia
|
1.2%
3/250 • Number of events 3 • Primary Endpoint (30days)
|
|
General disorders
Puncture site haemorrhage
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
General disorders
Asthenia
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
General disorders
Implant site discharge
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
General disorders
Implant site haematoma
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
General disorders
Multi-organ failure
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Vascular disorders
Total
|
10.8%
27/250 • Number of events 27 • Primary Endpoint (30days)
|
|
Vascular disorders
Haemorrhage
|
2.4%
6/250 • Number of events 6 • Primary Endpoint (30days)
|
|
Vascular disorders
Hypotension
|
2.4%
6/250 • Number of events 6 • Primary Endpoint (30days)
|
|
Vascular disorders
Femoral artery dissection
|
2.0%
5/250 • Number of events 5 • Primary Endpoint (30days)
|
|
Vascular disorders
Haematoma
|
1.2%
3/250 • Number of events 3 • Primary Endpoint (30days)
|
|
Vascular disorders
Angiopathy
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
Vascular disorders
Arterial haemorrhage
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Vascular disorders
Arterial rupture
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Vascular disorders
Hypertension
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Vascular disorders
Peripheral artery dissection
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Nervous system disorders
Total
|
6.4%
16/250 • Number of events 19 • Primary Endpoint (30days)
|
|
Nervous system disorders
Cerebrovascular accident
|
2.4%
6/250 • Number of events 6 • Primary Endpoint (30days)
|
|
Nervous system disorders
Ischaemic stroke
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
Nervous system disorders
Cerebellar haematoma
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Nervous system disorders
Cognitive disorder
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Nervous system disorders
Coma
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Nervous system disorders
Embolic stroke
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Nervous system disorders
Hemiparesis
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Nervous system disorders
Motor neurone disease
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Nervous system disorders
Syncope
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Infections and infestations
Total
|
7.2%
18/250 • Number of events 18 • Primary Endpoint (30days)
|
|
Infections and infestations
Pneumonia
|
1.6%
4/250 • Number of events 4 • Primary Endpoint (30days)
|
|
Infections and infestations
Urinary tract infection
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
Infections and infestations
Bronchiectasis
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Infections and infestations
Cellulitis
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Infections and infestations
Implant site infection
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Infections and infestations
Infection
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Infections and infestations
Influenza
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Infections and infestations
Osteomyelitis
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Infections and infestations
Puncture site infection
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Infections and infestations
Pyelonephritis
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Infections and infestations
Sepsis
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Infections and infestations
Staphylococcal infection
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Infections and infestations
Viral infection
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Respiratory, thoracic and mediastinal disorders
Total
|
4.8%
12/250 • Number of events 13 • Primary Endpoint (30days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.2%
3/250 • Number of events 3 • Primary Endpoint (30days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Blood and lymphatic system disorders
Total
|
4.8%
12/250 • Number of events 12 • Primary Endpoint (30days)
|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
8/250 • Number of events 8 • Primary Endpoint (30days)
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
1.6%
4/250 • Number of events 4 • Primary Endpoint (30days)
|
|
Injury, poisoning and procedural complications
Total
|
3.6%
9/250 • Number of events 9 • Primary Endpoint (30days)
|
|
Injury, poisoning and procedural complications
Device failure
|
1.2%
3/250 • Number of events 3 • Primary Endpoint (30days)
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Injury, poisoning and procedural complications
Device migration
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Gastrointestinal disorders
Total
|
3.2%
8/250 • Number of events 8 • Primary Endpoint (30days)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Gastrointestinal disorders
Haematemesis
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Gastrointestinal disorders
Intestinal functional disorder
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Gastrointestinal disorders
Melaena
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Investigations
Total
|
3.2%
8/250 • Number of events 8 • Primary Endpoint (30days)
|
|
Investigations
Haemoglobin decreased
|
2.4%
6/250 • Number of events 6 • Primary Endpoint (30days)
|
|
Investigations
C-reactive protein increased
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Investigations
Cardiac enzymes increased
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Psychiatric disorders
Total
|
2.0%
5/250 • Number of events 5 • Primary Endpoint (30days)
|
|
Psychiatric disorders
Delirium
|
1.2%
3/250 • Number of events 3 • Primary Endpoint (30days)
|
|
Psychiatric disorders
Confusional state
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Psychiatric disorders
Disorientation
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Renal and urinary disorders
Total
|
1.6%
4/250 • Number of events 4 • Primary Endpoint (30days)
|
|
Renal and urinary disorders
Bladder disorder
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Renal and urinary disorders
Renal disorder
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Renal and urinary disorders
Renal failure chronic
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Renal and urinary disorders
Urinary retention
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Eye disorders
Total
|
0.80%
2/250 • Number of events 2 • Primary Endpoint (30days)
|
|
Eye disorders
Cataract
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Eye disorders
Eyelid ptosis
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Congenital, familial and genetic disorders
Total
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Immune system disorders
Total
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Immune system disorders
Drug hypersensitivity
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Metabolism and nutrition disorders
Total
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Total
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Reproductive system and breast disorders
Total
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Reproductive system and breast disorders
Oedema genital
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Skin and subcutaneous tissue disorders
Total
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.40%
1/250 • Number of events 1 • Primary Endpoint (30days)
|
Other adverse events
| Measure |
REPRISE II and Extension Overall
n=250 participants at risk
Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.
Lotus Valve System: - bioprosthetic bovine pericardial aortic valve
\- delivery system
|
|---|---|
|
Cardiac disorders
Total
|
42.4%
106/250 • Number of events 129 • Primary Endpoint (30days)
|
|
Cardiac disorders
Bundle branch block left
|
39.2%
98/250 • Number of events 99 • Primary Endpoint (30days)
|
|
Cardiac disorders
Atrioventricular block first degree
|
6.8%
17/250 • Number of events 17 • Primary Endpoint (30days)
|
|
Cardiac disorders
Atrial fibrillation
|
5.2%
13/250 • Number of events 13 • Primary Endpoint (30days)
|
|
General disorders
Total
|
24.4%
61/250 • Number of events 98 • Primary Endpoint (30days)
|
|
General disorders
Catheter site haematoma
|
14.0%
35/250 • Number of events 48 • Primary Endpoint (30days)
|
|
General disorders
Catheter site haemorrhage
|
10.0%
25/250 • Number of events 26 • Primary Endpoint (30days)
|
|
General disorders
Pyrexia
|
9.2%
23/250 • Number of events 24 • Primary Endpoint (30days)
|
|
Vascular disorders
Total
|
14.0%
35/250 • Number of events 35 • Primary Endpoint (30days)
|
|
Vascular disorders
Hypertension
|
7.2%
18/250 • Number of events 18 • Primary Endpoint (30days)
|
|
Vascular disorders
Hypotension
|
6.8%
17/250 • Number of events 17 • Primary Endpoint (30days)
|
|
Infections and infestations
Total
|
7.6%
19/250 • Number of events 19 • Primary Endpoint (30days)
|
|
Infections and infestations
Urinary tract infection
|
7.6%
19/250 • Number of events 19 • Primary Endpoint (30days)
|
|
Blood and lymphatic system disorders
Total
|
6.8%
17/250 • Number of events 17 • Primary Endpoint (30days)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.8%
17/250 • Number of events 17 • Primary Endpoint (30days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER