Trial Outcomes & Findings for Medtronic HAMMOCK Post Approval Study (NCT NCT03139721)
NCT ID: NCT03139721
Last Updated: 2024-08-23
Results Overview
Number of deaths, reinterventions, or explants related to the valve
Recruitment status
COMPLETED
Target enrollment
122 participants
Primary outcome timeframe
1-year post implant
Results posted on
2024-08-23
Participant Flow
122 subject were consented to participate. 22 were withdrawn from the study prior to study device implant.
Participant milestones
| Measure |
Aortic Valve Replacements
Subjects that received an aortic valve replacement
|
Mitral Valve Replacements
Subjects that received a mitral valve replacement
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
11
|
|
Overall Study
Primary Endpoint
|
83
|
10
|
|
Overall Study
COMPLETED
|
68
|
10
|
|
Overall Study
NOT COMPLETED
|
21
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline demographics only includes subjects implanted with a study valve.
Baseline characteristics by cohort
| Measure |
Aortic Valve Replacements
n=89 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=11 Participants
Subjects requiring mitral valve replacement
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.6 Years
STANDARD_DEVIATION 7.8 • n=5 Participants • Baseline demographics only includes subjects implanted with a study valve.
|
69.1 Years
STANDARD_DEVIATION 8.2 • n=7 Participants • Baseline demographics only includes subjects implanted with a study valve.
|
69.6 Years
STANDARD_DEVIATION 7.8 • n=5 Participants • Baseline demographics only includes subjects implanted with a study valve.
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
4 Participants
n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
34 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
7 Participants
n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
66 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
1 Participants
n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
1 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
10 Participants
n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
85 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
0 Participants
n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
14 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
0 Participants
n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
1 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
0 Participants
n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
1 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
0 Participants
n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
0 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
1 Participants
n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
1 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
10 Participants
n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
83 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
0 Participants
n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
0 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
0 Participants
n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
14 Participants
n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants • Region of enrollment only includes subjects implanted with a study valve
|
11 participants
n=7 Participants • Region of enrollment only includes subjects implanted with a study valve
|
66 participants
n=5 Participants • Region of enrollment only includes subjects implanted with a study valve
|
|
Region of Enrollment
Poland
|
20 participants
n=5 Participants • Region of enrollment only includes subjects implanted with a study valve
|
0 participants
n=7 Participants • Region of enrollment only includes subjects implanted with a study valve
|
20 participants
n=5 Participants • Region of enrollment only includes subjects implanted with a study valve
|
|
Region of Enrollment
Germany
|
14 participants
n=5 Participants • Region of enrollment only includes subjects implanted with a study valve
|
0 participants
n=7 Participants • Region of enrollment only includes subjects implanted with a study valve
|
14 participants
n=5 Participants • Region of enrollment only includes subjects implanted with a study valve
|
|
Height
|
170.3 cm
STANDARD_DEVIATION 9.7 • n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
170.9 cm
STANDARD_DEVIATION 9.2 • n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
170.4 cm
STANDARD_DEVIATION 9.6 • n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Weight
|
90.2 kg
STANDARD_DEVIATION 19.4 • n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
88.2 kg
STANDARD_DEVIATION 24.5 • n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
90.0 kg
STANDARD_DEVIATION 19.9 • n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Body Surface Area
|
2.1 m^2
STANDARD_DEVIATION 0.3 • n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
2.0 m^2
STANDARD_DEVIATION 0.3 • n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
2.1 m^2
STANDARD_DEVIATION 0.3 • n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
|
Body Mass Index
|
31.0 kg/m^2
STANDARD_DEVIATION 6.1 • n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
30.6 kg/m^2
STANDARD_DEVIATION 9.8 • n=7 Participants • Baseline demographics only include subjects implanted with a study valve
|
31.0 kg/m^2
STANDARD_DEVIATION 6.5 • n=5 Participants • Baseline demographics only include subjects implanted with a study valve
|
PRIMARY outcome
Timeframe: 1-year post implantNumber of deaths, reinterventions, or explants related to the valve
Outcome measures
| Measure |
Aortic Valve Replacements
n=89 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=11 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Number of Deaths, Reinterventions, or Explants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3-years post implantNumber of deaths, reinterventions, or explants related to the valve
Outcome measures
| Measure |
Aortic Valve Replacements
n=89 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=11 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Number of Deaths, Reinterventions, or Explants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1-year post implantMeasured by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=81 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=10 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Mean Gradient (mmHg)
|
14.3 mmHg
Standard Deviation 5.1
|
4.6 mmHg
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 1-year post implantMeasured by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=81 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=10 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Peak Gradient (mmHg)
|
25.6 mmHg
Standard Deviation 9.2
|
11.2 mmHg
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 1-year post implantMeasured by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=72 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=10 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Effective Orifice Area (EOA)
|
1.41 cm^2
Standard Deviation 0.37
|
1.35 cm^2
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 1-year post implantEOA Measured by echocardiogram via Echo Core Lab/Body Surface Area
Outcome measures
| Measure |
Aortic Valve Replacements
n=72 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=10 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Effective Orifice Area Index (EOAi)
|
0.71 cm^2/m^2
Standard Deviation 0.18
|
0.70 cm^2/m^2
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: 1-year post implantMeasured by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=70 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=10 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Cardiac Output
|
4.7 L/min
Standard Deviation 1.1
|
4.1 L/min
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 1-year post implantCardiac Output Measured by echocardiogram via Echo Core Lab/Body Surface Area
Outcome measures
| Measure |
Aortic Valve Replacements
n=70 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=10 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Cardiac Index
|
2.4 L/min/m^2
Standard Deviation 0.5
|
2.1 L/min/m^2
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 1-year post implantThe performance index is a measure of how effectively the external dimension of the valve is used to provide forward flow, normalized to the valve size. It is defined as effective orifice area divided by the tissue annulus area, where the tissue annulus area is calculated from the prosthetic valve size.
Outcome measures
| Measure |
Aortic Valve Replacements
n=72 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=10 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Performance Index
|
0.4 Units do not exist
Standard Deviation 0.1
|
0.2 Units do not exist
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 1-year post implantMeasured by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=81 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=10 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Transvalvular Regurgitation
None
|
67 Participants
|
7 Participants
|
|
Transvalvular Regurgitation
Trace
|
6 Participants
|
2 Participants
|
|
Transvalvular Regurgitation
Mild
|
1 Participants
|
1 Participants
|
|
Transvalvular Regurgitation
Moderate
|
0 Participants
|
0 Participants
|
|
Transvalvular Regurgitation
Moderate to Severe
|
0 Participants
|
0 Participants
|
|
Transvalvular Regurgitation
Severe
|
0 Participants
|
0 Participants
|
|
Transvalvular Regurgitation
Not recorded/unable to assess
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1-year post implantMeasured by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=81 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=10 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Paravalvular Regurgitation
None
|
64 Participants
|
9 Participants
|
|
Paravalvular Regurgitation
Trace
|
1 Participants
|
0 Participants
|
|
Paravalvular Regurgitation
Mild
|
6 Participants
|
0 Participants
|
|
Paravalvular Regurgitation
Moderate
|
3 Participants
|
0 Participants
|
|
Paravalvular Regurgitation
Moderate to Severe
|
0 Participants
|
0 Participants
|
|
Paravalvular Regurgitation
Severe
|
0 Participants
|
0 Participants
|
|
Paravalvular Regurgitation
Not recorded/unable to assess
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1-year post implantMeasured by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=81 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=10 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Total Regurgitation
None
|
58 Participants
|
6 Participants
|
|
Total Regurgitation
Trace
|
7 Participants
|
2 Participants
|
|
Total Regurgitation
Mild
|
9 Participants
|
1 Participants
|
|
Total Regurgitation
Moderate
|
3 Participants
|
0 Participants
|
|
Total Regurgitation
Moderate to Severe
|
0 Participants
|
0 Participants
|
|
Total Regurgitation
Severe
|
0 Participants
|
0 Participants
|
|
Total Regurgitation
Not recorded/unable to assess
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1-year post implantMeasure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Outcome measures
| Measure |
Aortic Valve Replacements
n=75 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=10 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
New York Heart Association (NYHA) Classification
NYHA I
|
51 Participants
|
8 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA II
|
21 Participants
|
2 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA III
|
3 Participants
|
0 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA IV
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3-years post implantMeasured by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=59 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=6 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Mean Gradient
|
14.3 mmHg
Standard Deviation 4.4
|
5.0 mmHg
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 3-years post implantMeasured by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=59 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=6 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Peak Gradient
|
26.5 mmHg
Standard Deviation 8.3
|
11.3 mmHg
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: 3-years post implantMeasured by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=48 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=6 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Effective Orifice Area (EOA)
|
1.41 cm^2
Standard Deviation 0.32
|
1.26 cm^2
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: 3-years post implantEOA Measured by echocardiogram via Echo Core Lab/Body Surface Area
Outcome measures
| Measure |
Aortic Valve Replacements
n=48 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=6 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Effective Orifice Area Index (EOAi)
|
0.71 cm^2/m^2
Standard Deviation 0.14
|
0.63 cm^2/m^2
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: 3-years post implantMeasure by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=49 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=7 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Cardiac Output
|
4.7 L/min
Standard Deviation 1.0
|
3.6 L/min
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 3-years post implantCardiac output measured by echocardiogram via Echo Core Lab/Body Surface Area
Outcome measures
| Measure |
Aortic Valve Replacements
n=49 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=7 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Cardiac Index
|
2.4 L/min/m^2
Standard Deviation 0.5
|
1.8 L/min/m^2
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 3-years post implantThe performance index is a measure of how effectively the external dimension of the valve is used to provide forward flow, normalized to the valve size. It is defined as effective orifice area divided by the tissue annulus area, where the tissue annulus area is calculated from the prosthetic valve size.
Outcome measures
| Measure |
Aortic Valve Replacements
n=48 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=6 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Performance Index
|
0.4 Units do not exist
Standard Deviation 0.1
|
0.2 Units do not exist
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 3-years post implantMeasured by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=59 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=9 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Transvalvular Regurgitation
Mild
|
1 Participants
|
1 Participants
|
|
Transvalvular Regurgitation
None
|
50 Participants
|
4 Participants
|
|
Transvalvular Regurgitation
Trace
|
1 Participants
|
4 Participants
|
|
Transvalvular Regurgitation
Moderate
|
0 Participants
|
0 Participants
|
|
Transvalvular Regurgitation
Moderate to Severe
|
0 Participants
|
0 Participants
|
|
Transvalvular Regurgitation
Severe
|
0 Participants
|
0 Participants
|
|
Transvalvular Regurgitation
Not recorded/unable to assess
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3-years post implantMeasured by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=59 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=9 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Paravalvular Regurgitation
None
|
46 Participants
|
9 Participants
|
|
Paravalvular Regurgitation
Trace
|
1 Participants
|
0 Participants
|
|
Paravalvular Regurgitation
Mild
|
4 Participants
|
0 Participants
|
|
Paravalvular Regurgitation
Moderate
|
1 Participants
|
0 Participants
|
|
Paravalvular Regurgitation
Moderate to Severe
|
0 Participants
|
0 Participants
|
|
Paravalvular Regurgitation
Severe
|
0 Participants
|
0 Participants
|
|
Paravalvular Regurgitation
Not recorded/Unable to assess
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3-years post implantMeasured by echocardiogram via Echo Core Lab
Outcome measures
| Measure |
Aortic Valve Replacements
n=59 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=9 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Total Regurgitation
None
|
44 Participants
|
4 Participants
|
|
Total Regurgitation
Trace
|
3 Participants
|
4 Participants
|
|
Total Regurgitation
Mild
|
6 Participants
|
1 Participants
|
|
Total Regurgitation
Moderate
|
1 Participants
|
0 Participants
|
|
Total Regurgitation
Moderate to Severe
|
2 Participants
|
0 Participants
|
|
Total Regurgitation
Severe
|
0 Participants
|
0 Participants
|
|
Total Regurgitation
Not recorded/Unable to assess
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3-years post implantMeasure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Outcome measures
| Measure |
Aortic Valve Replacements
n=66 Participants
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=9 Participants
Subjects requiring mitral valve replacement
|
|---|---|---|
|
New York Heart Association (NYHA) Classification
NYHA I
|
51 Participants
|
7 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA II
|
14 Participants
|
1 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA III
|
1 Participants
|
1 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA IV
|
0 Participants
|
0 Participants
|
Adverse Events
Aortic Valve Replacements
Serious events: 55 serious events
Other events: 52 other events
Deaths: 8 deaths
Mitral Valve Replacements
Serious events: 7 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Aortic Valve Replacements
n=89 participants at risk
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=11 participants at risk
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
4/89 • Number of events 5 • 3 years
|
0.00%
0/11 • 3 years
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
3/89 • Number of events 3 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.2%
2/89 • Number of events 2 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Arrhythmia Supraventricular
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Atrial Fibrillation
|
5.6%
5/89 • Number of events 5 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Atrial Rupture
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Atrioventricular Block Complete
|
2.2%
2/89 • Number of events 2 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/89 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Cardiac disorders
Cardiac Arrest
|
2.2%
2/89 • Number of events 2 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Cardiac Failure Acute
|
4.5%
4/89 • Number of events 4 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Cardiac Tamponade
|
2.2%
2/89 • Number of events 2 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Cardiogenic Shock
|
1.1%
1/89 • Number of events 1 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Coronary Artery Disease
|
1.1%
1/89 • Number of events 1 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Low Cardiac Output Syndrome
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Pericardial Effusion
|
2.2%
2/89 • Number of events 2 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Pericardial Haemorrhage
|
2.2%
2/89 • Number of events 2 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Right Ventricular Dysfunction
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Sinus Node Dysfunction
|
4.5%
4/89 • Number of events 4 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Tachycardia
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Cardiac disorders
Tricuspid Valve Incompetence
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Ventricular Asystole
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Eye disorders
Retinal Artery Occlusion
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Gastrointestinal disorders
Abdominal Compartment Syndrome
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Gastrointestinal disorders
Alcoholic Pancreatitis
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Gastrointestinal disorders
Inguinal Hernia
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Gastrointestinal disorders
Oesophageal Stenosis
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
1.1%
1/89 • Number of events 1 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Umbilical Hernia
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
2.2%
2/89 • Number of events 2 • 3 years
|
0.00%
0/11 • 3 years
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Infections and infestations
Abscess Limb
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Infections and infestations
Appendicitis
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Infections and infestations
Bacteraemia
|
2.2%
2/89 • Number of events 2 • 3 years
|
0.00%
0/11 • 3 years
|
|
Infections and infestations
Cellulitis
|
1.1%
1/89 • Number of events 1 • 3 years
|
9.1%
1/11 • Number of events 2 • 3 years
|
|
Infections and infestations
Covid-19
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Infections and infestations
Endocarditis
|
1.1%
1/89 • Number of events 1 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Infections and infestations
Endocarditis Enterococcal
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Infections and infestations
Influenza
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Infections and infestations
Pneumonia
|
2.2%
2/89 • Number of events 2 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Infections and infestations
Postoperative Wound Infection
|
2.2%
2/89 • Number of events 3 • 3 years
|
0.00%
0/11 • 3 years
|
|
Infections and infestations
Pulmonary Sepsis
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Infections and infestations
Staphylococcal Abscess
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Infections and infestations
Urinary Tract Infection
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Infections and infestations
Wound Infection
|
2.2%
2/89 • Number of events 2 • 3 years
|
0.00%
0/11 • 3 years
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Injury, poisoning and procedural complications
Cardiac Vein Perforation
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Carotid Artery Restenosis
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Fracture
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Injury, poisoning and procedural complications
Postpericardiotomy Syndrome
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Injury, poisoning and procedural complications
Procedural Pneumothorax
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/89 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Injury, poisoning and procedural complications
Ulna Fracture
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Investigations
Human Metapneumovirus Test
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Compartment Syndrome
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Of Colon
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Nervous system disorders
Carotid Artery Stenosis
|
1.1%
1/89 • Number of events 1 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Nervous system disorders
Cerebral Infarction
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Nervous system disorders
Encephalopathy
|
1.1%
1/89 • Number of events 1 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Nervous system disorders
Epilepsy
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Nervous system disorders
Hepatic Encephalopathy
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Nervous system disorders
Ischaemic Stroke
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Nervous system disorders
Sciatica
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
5.6%
5/89 • Number of events 5 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
End Stage Renal Disease
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Oliguria
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Renal and urinary disorders
Renal Impairment
|
2.2%
2/89 • Number of events 2 • 3 years
|
0.00%
0/11 • 3 years
|
|
Renal and urinary disorders
Urinary Bladder Haemorrhage
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Scrotal Oedema
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
3.4%
3/89 • Number of events 4 • 3 years
|
9.1%
1/11 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.7%
6/89 • Number of events 6 • 3 years
|
0.00%
0/11 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Air Leakage
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Surgical and medical procedures
Thoracic Cavity Drainage
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Vascular disorders
Aortic Aneurysm
|
2.2%
2/89 • Number of events 2 • 3 years
|
0.00%
0/11 • 3 years
|
|
Vascular disorders
Aortic Dissection
|
2.2%
2/89 • Number of events 2 • 3 years
|
0.00%
0/11 • 3 years
|
|
Vascular disorders
Aortic Stenosis
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Vascular disorders
Hypotension
|
2.2%
2/89 • Number of events 2 • 3 years
|
0.00%
0/11 • 3 years
|
|
Vascular disorders
Jugular Vein Thrombosis
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Vascular disorders
Phlebitis
|
1.1%
1/89 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
Other adverse events
| Measure |
Aortic Valve Replacements
n=89 participants at risk
Subjects requiring aortic valve replacement
|
Mitral Valve Replacements
n=11 participants at risk
Subjects requiring mitral valve replacement
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.2%
18/89 • Number of events 18 • 3 years
|
54.5%
6/11 • Number of events 6 • 3 years
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
0.00%
0/89 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/89 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
20.2%
18/89 • Number of events 19 • 3 years
|
63.6%
7/11 • Number of events 7 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.6%
13/89 • Number of events 13 • 3 years
|
90.9%
10/11 • Number of events 10 • 3 years
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Atrial Fibrillation
|
23.6%
21/89 • Number of events 21 • 3 years
|
36.4%
4/11 • Number of events 4 • 3 years
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.00%
0/89 • 3 years
|
36.4%
4/11 • Number of events 4 • 3 years
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/89 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Cardiac disorders
Bundle Branch Block Left
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Nodal Rhythm
|
0.00%
0/89 • 3 years
|
36.4%
4/11 • Number of events 4 • 3 years
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Pericardial Rub
|
0.00%
0/89 • 3 years
|
27.3%
3/11 • Number of events 3 • 3 years
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/89 • 3 years
|
27.3%
3/11 • Number of events 3 • 3 years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Eye disorders
Vision Blurred
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
5.6%
5/89 • Number of events 5 • 3 years
|
45.5%
5/11 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/89 • 3 years
|
63.6%
7/11 • Number of events 7 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
General disorders
Asthenia
|
5.6%
5/89 • Number of events 5 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
General disorders
Impaired Healing
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
General disorders
Oedema Peripheral
|
7.9%
7/89 • Number of events 7 • 3 years
|
0.00%
0/11 • 3 years
|
|
General disorders
Physical Deconditioning
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
General disorders
Pyrexia
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Anaemia Postoperative
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Depression Postoperative
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Face Injury
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Investigations
Blood Urea Nitrogen/Creatinine Ratio Increased
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Investigations
Cardiac Index Decreased
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Investigations
Prothrombin Time Ratio Increased
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
13.5%
12/89 • Number of events 12 • 3 years
|
90.9%
10/11 • Number of events 10 • 3 years
|
|
Metabolism and nutrition disorders
Fluid Overload
|
6.7%
6/89 • Number of events 7 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.5%
12/89 • Number of events 12 • 3 years
|
90.9%
10/11 • Number of events 10 • 3 years
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/89 • 3 years
|
27.3%
3/11 • Number of events 3 • 3 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/89 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.7%
6/89 • Number of events 6 • 3 years
|
36.4%
4/11 • Number of events 4 • 3 years
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/89 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.6%
5/89 • Number of events 5 • 3 years
|
45.5%
5/11 • Number of events 5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Air Leakage
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/89 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Vascular Disorder
|
0.00%
0/89 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
7.9%
7/89 • Number of events 8 • 3 years
|
72.7%
8/11 • Number of events 8 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/89 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Emphysema
|
0.00%
0/89 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Vascular disorders
Haematoma
|
0.00%
0/89 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Vascular disorders
Hypertension
|
9.0%
8/89 • Number of events 8 • 3 years
|
54.5%
6/11 • Number of events 6 • 3 years
|
|
Vascular disorders
Hypotension
|
9.0%
8/89 • Number of events 9 • 3 years
|
81.8%
9/11 • Number of events 9 • 3 years
|
Additional Information
Jessica Halverson, Clinical Research Director
Medtronic
Phone: 763-514-9756
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI is restricted to publish results until the Sponsor has published the results.
- Publication restrictions are in place
Restriction type: OTHER