Trial Outcomes & Findings for PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate (NCT NCT03222128)
NCT ID: NCT03222128
Last Updated: 2025-01-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1074 participants
Primary outcome timeframe
1 year
Results posted on
2025-01-03
Participant Flow
Subjects were screened and enrolled at 51 sites in the US
The As-Treated population was 1074 The Valve-Implanted population was 1069
Participant milestones
| Measure |
PIIS3i - SAPIEN 3
PIIS3i - SAPIEN 3 is Operable Group
TAVR: Implantation of the SAPIEN 3
|
|---|---|
|
Overall Study
STARTED
|
1074
|
|
Overall Study
Valve-Implanted
|
1069
|
|
Overall Study
COMPLETED
|
968
|
|
Overall Study
NOT COMPLETED
|
106
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate
Baseline characteristics by cohort
| Measure |
PIIS3i - SAPIEN 3
n=1074 Participants
PIIS3i - SAPIEN 3 is Operable Group
TAVR: Implantation of the SAPIEN 3
|
|---|---|
|
Age, Continuous
|
81.9 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
412 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
662 Participants
n=5 Participants
|
|
STS Score
|
5.3 units on a scale
STANDARD_DEVIATION 1.29 • n=5 Participants
|
|
NYHA Classification III/IV
|
780 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: AI as a factor in this value; only 964/1069 patients had ECHO data.
Outcome measures
| Measure |
PIIS3i - SAPIEN 3
n=964 Participants
PIIS3i - SAPIEN 3 is Operable Group
TAVR: Implantation of the SAPIEN 3
|
|---|---|
|
Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate
|
125 Participants
|
SECONDARY outcome
Timeframe: 30 DaysOutcome measures
| Measure |
PIIS3i - SAPIEN 3
n=1069 Participants
PIIS3i - SAPIEN 3 is Operable Group
TAVR: Implantation of the SAPIEN 3
|
|---|---|
|
Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days
|
196 Participants
|
Adverse Events
PIIS3i - SAPIEN 3
Serious events: 592 serious events
Other events: 861 other events
Deaths: 75 deaths
Serious adverse events
| Measure |
PIIS3i - SAPIEN 3
n=1069 participants at risk
PIIS3i - SAPIEN 3 is Operable Group
TAVR: Implantation of the SAPIEN 3
|
|---|---|
|
Metabolism and nutrition disorders
Abnormal lab value
|
2.1%
22/1069 • Number of events 26 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Access site and access related vascular injury - Dissection
|
1.0%
11/1069 • Number of events 11 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Access site and access related vascular injury - Distal embolization (noncerebral) from vascular sou
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Injury, poisoning and procedural complications
Access site and access related vascular injury - Failure of percutaneous access site closure
|
0.75%
8/1069 • Number of events 8 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Access site and access related vascular injury - Hematoma
|
0.47%
5/1069 • Number of events 5 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Access site and access related vascular injury - Other
|
0.75%
8/1069 • Number of events 8 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Access site and access related vascular injury - Perforation
|
0.37%
4/1069 • Number of events 4 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Access site and access related vascular injury - Pseudoaneurysm
|
0.37%
4/1069 • Number of events 4 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Access site and access related vascular injury - Rupture
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Access site and access related vascular injury - Stenosis
|
0.47%
5/1069 • Number of events 5 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Access site and access related vascular injury - Ventricular rupture (Apical rupture)
|
0.19%
2/1069 • Number of events 2 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Blood and lymphatic system disorders
Anemia/Hemolytic anemia
|
2.3%
25/1069 • Number of events 29 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Injury, poisoning and procedural complications
Anesthesia related complication - Confusion
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Injury, poisoning and procedural complications
Anesthesia related complication - Other
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Angina/Cardiac chest pain
|
1.5%
16/1069 • Number of events 17 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.19%
2/1069 • Number of events 2 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Aortic insufficiency/Regurgitation PV leak - Non structural dysfunction
|
0.65%
7/1069 • Number of events 7 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
General disorders
Aortic insufficiency/Regurgitation PV leak - Structural dysfunction
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
General disorders
Aortic insufficiency/Regurgitation non valvular cause
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Arrhythmia/Conduction system injury (defect)
|
18.2%
195/1069 • Number of events 216 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Injury, poisoning and procedural complications
Bleeding - Hemorrhage
|
10.4%
111/1069 • Number of events 134 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Cardiac arrest
|
1.6%
17/1069 • Number of events 17 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Cardiac tamponade/Pericardial effusion
|
1.3%
14/1069 • Number of events 14 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Cardiogenic shock
|
0.19%
2/1069 • Number of events 3 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Nervous system disorders
Carotid artery disease
|
0.47%
5/1069 • Number of events 5 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Coronary artery disease/Coronary ischemia
|
0.75%
8/1069 • Number of events 11 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Coronary flow obstruction/Transvalvular flow disturbance
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Psychiatric disorders
Delirium
|
0.28%
3/1069 • Number of events 3 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Injury, poisoning and procedural complications
Device migration/malposition requiring intervention
|
0.28%
3/1069 • Number of events 3 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Ear and labyrinth disorders
Edema
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Nervous system disorders
Encephalopathy
|
0.28%
3/1069 • Number of events 3 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Metabolism and nutrition disorders
Exercise intolerance or weakness
|
0.19%
2/1069 • Number of events 2 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Gastrointestinal disorders
Gastro Intestinal event - Non-hemorrhagic
|
2.9%
31/1069 • Number of events 33 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Renal and urinary disorders
Genito-Urinary event - Non-hemorrhagic
|
1.6%
17/1069 • Number of events 17 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Heart failure/CHF/Low output failure
|
7.1%
76/1069 • Number of events 96 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
General disorders
Hemolysis
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Hypertension
|
0.94%
10/1069 • Number of events 10 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Hypotension
|
1.0%
11/1069 • Number of events 11 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Infections and infestations
Infection - Access site infection
|
0.37%
4/1069 • Number of events 4 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Infections and infestations
Infection - Bacteremia
|
0.47%
5/1069 • Number of events 5 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Infections and infestations
Infection - Endocarditis
|
0.75%
8/1069 • Number of events 8 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Infections and infestations
Infection - Other
|
2.4%
26/1069 • Number of events 27 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Infections and infestations
Infection - Respiratory infection
|
5.1%
55/1069 • Number of events 63 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Infections and infestations
Infection - Sepsis
|
2.6%
28/1069 • Number of events 29 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Infections and infestations
Infection - Urinary tract infection
|
1.9%
20/1069 • Number of events 21 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Investigations
Ischemia
|
0.75%
8/1069 • Number of events 10 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Myocardial Infarction
|
1.2%
13/1069 • Number of events 15 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Investigations
Mental state change (not neurological) - Confusion
|
0.47%
5/1069 • Number of events 5 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Investigations
Mental state change (not neurological) - Dementia
|
0.19%
2/1069 • Number of events 2 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Investigations
Mental state change (not neurological) - Depression
|
0.19%
2/1069 • Number of events 2 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Miscellaneous - Cancer
|
1.6%
17/1069 • Number of events 17 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Investigations
Miscellaneous - Drug reaction
|
0.19%
2/1069 • Number of events 2 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Injury, poisoning and procedural complications
Miscellaneous - Fall
|
2.2%
23/1069 • Number of events 25 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
General disorders
Miscellaneous - Other
|
1.4%
15/1069 • Number of events 15 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Social circumstances
Miscellaneous - Suicide
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Mitral valve injury or insufficiency
|
0.28%
3/1069 • Number of events 3 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
General disorders
Multi organ failure
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Injury, poisoning and procedural complications
Musculoskeletal - Fracture
|
3.1%
33/1069 • Number of events 36 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - Pain
|
2.3%
25/1069 • Number of events 25 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Nervous system disorders
Neurological - Change in level of consciousness
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Nervous system disorders
Neurological - Cognitive impairment
|
0.19%
2/1069 • Number of events 2 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Nervous system disorders
Neurological - Dysphasia/Aphasia
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Nervous system disorders
Neurological - Hemiparesis (One sided body weakness)
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Nervous system disorders
Neurological - Hemorrhagic stroke
|
0.75%
8/1069 • Number of events 8 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Nervous system disorders
Neurological - Ischemic stroke
|
2.2%
24/1069 • Number of events 25 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Nervous system disorders
Neurological - Other
|
0.56%
6/1069 • Number of events 7 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Nervous system disorders
Neurological - Other new neurological sign consistent with stroke
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Nervous system disorders
Neurological - TIA
|
0.94%
10/1069 • Number of events 12 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Nervous system disorders
Neurological - Undetermined stroke
|
0.65%
7/1069 • Number of events 8 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Pericarditis
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Renal and urinary disorders
Renal insufficiency or renal failure
|
2.9%
31/1069 • Number of events 34 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Aspiration
|
0.19%
2/1069 • Number of events 3 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Atelectasis
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Dyspnea
|
1.4%
15/1069 • Number of events 15 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Other
|
1.6%
17/1069 • Number of events 18 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Pneumothorax
|
0.19%
2/1069 • Number of events 2 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Pulmonary edema
|
0.19%
2/1069 • Number of events 2 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Pulmonary effusion
|
1.6%
17/1069 • Number of events 17 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Respiratory failure
|
3.0%
32/1069 • Number of events 37 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Syncope
|
1.3%
14/1069 • Number of events 15 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
14/1069 • Number of events 15 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Thromboembolic event
|
1.2%
13/1069 • Number of events 13 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
General disorders
Unknown cause of death
|
0.47%
5/1069 • Number of events 5 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Valve thrombosis
|
0.09%
1/1069 • Number of events 1 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Vascular complication - Non-access related
|
1.5%
16/1069 • Number of events 18 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
General disorders
Other
|
3.6%
38/1069 • Number of events 41 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
Other adverse events
| Measure |
PIIS3i - SAPIEN 3
n=1069 participants at risk
PIIS3i - SAPIEN 3 is Operable Group
TAVR: Implantation of the SAPIEN 3
|
|---|---|
|
Investigations
Abnormal lab value
|
13.5%
144/1069 • Number of events 186 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Blood and lymphatic system disorders
Anemia/Hemolytic anemia
|
12.0%
128/1069 • Number of events 140 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Aortic insufficiency/Regurgitation PV leak - Non structural dysfunction
|
5.1%
55/1069 • Number of events 55 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Arrhythmia/Conduction system injury (defect)
|
28.0%
299/1069 • Number of events 357 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Bleeding - Hemorrhage
|
19.8%
212/1069 • Number of events 240 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Gastrointestinal disorders
Gastro Intestinal event - Non-hemorrhagic
|
6.2%
66/1069 • Number of events 77 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Renal and urinary disorders
Genito-Urinary event - Non-hemorrhagic
|
7.8%
83/1069 • Number of events 88 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Cardiac disorders
Heart failure/CHF/Low output failure
|
8.9%
95/1069 • Number of events 101 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Hypertension
|
5.3%
57/1069 • Number of events 59 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Vascular disorders
Hypotension
|
5.9%
63/1069 • Number of events 68 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Infections and infestations
Infection - Other
|
5.1%
55/1069 • Number of events 62 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Infections and infestations
Infection - Urinary tract infection
|
8.1%
87/1069 • Number of events 101 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Injury, poisoning and procedural complications
Miscellaneous - Fall
|
6.5%
70/1069 • Number of events 81 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Investigations
Miscellaneous - Other
|
6.1%
65/1069 • Number of events 72 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - Pain
|
7.6%
81/1069 • Number of events 94 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Renal and urinary disorders
Renal insufficiency or renal failure
|
10.9%
117/1069 • Number of events 134 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Pulmonary effusion
|
5.9%
63/1069 • Number of events 67 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.4%
101/1069 • Number of events 101 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
|
Investigations
Other
|
10.4%
111/1069 • Number of events 136 • The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place