Trial Outcomes & Findings for 5 Year Observation of Patients With PORTICO Valves (NCT NCT01802788)
NCT ID: NCT01802788
Last Updated: 2025-02-11
Results Overview
Percentage of participants that died for any reason at 1 year post implantation
Recruitment status
COMPLETED
Target enrollment
1032 participants
Primary outcome timeframe
1 year post implant
Results posted on
2025-02-11
Participant Flow
Of the 973 subjects who were screened in Cohort A, 941 underwent an implant attempt with a Portico THV. Subjects in Cohort B were implanted in previous St. Jude Medical sponsored regulatory (pre-market) investigations and first-in-human trials, and consented for participation after completion of 1 year follow-up in their initial study.
The first subject was enrolled on April 16, 2013 and the last subject was enrolled on June 28, 2017. Among the 973 subjects who were screened initially in Cohort A, 32 were excluded due to screen failures or exit without a Portico implant attempt. Hence only 941 subjects from Cohort A and 59 from Cohort B were considered for baseline, endpoint and safety analyses.
Participant milestones
| Measure |
Cohort A
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Overall Study
STARTED
|
941
|
59
|
|
Overall Study
COMPLETED
|
398
|
34
|
|
Overall Study
NOT COMPLETED
|
543
|
25
|
Reasons for withdrawal
| Measure |
Cohort A
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
102
|
5
|
|
Overall Study
Death
|
382
|
18
|
|
Overall Study
Lost to Follow-up
|
31
|
2
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Patient Non-Compliance
|
1
|
0
|
|
Overall Study
Study Stopped/Terminated at Site
|
5
|
0
|
|
Overall Study
Other Reasons
|
19
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=59 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
Total
n=1000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
82.4 years
STANDARD_DEVIATION 5.9 • n=941 Participants
|
82.3 years
STANDARD_DEVIATION 4.6 • n=59 Participants
|
82.4 years
STANDARD_DEVIATION 5.9 • n=1000 Participants
|
|
Sex: Female, Male
Female
|
618 Participants
n=941 Participants
|
37 Participants
n=59 Participants
|
655 Participants
n=1000 Participants
|
|
Sex: Female, Male
Male
|
323 Participants
n=941 Participants
|
22 Participants
n=59 Participants
|
345 Participants
n=1000 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
22 participants
n=941 Participants
|
0 participants
n=59 Participants
|
22 participants
n=1000 Participants
|
|
Region of Enrollment
Switzerland
|
4 participants
n=941 Participants
|
0 participants
n=59 Participants
|
4 participants
n=1000 Participants
|
|
Region of Enrollment
Spain
|
35 participants
n=941 Participants
|
0 participants
n=59 Participants
|
35 participants
n=1000 Participants
|
|
Region of Enrollment
Canada
|
60 participants
n=941 Participants
|
0 participants
n=59 Participants
|
60 participants
n=1000 Participants
|
|
Region of Enrollment
Netherlands
|
29 participants
n=941 Participants
|
12 participants
n=59 Participants
|
41 participants
n=1000 Participants
|
|
Region of Enrollment
Belgium
|
34 participants
n=941 Participants
|
0 participants
n=59 Participants
|
34 participants
n=1000 Participants
|
|
Region of Enrollment
Denmark
|
56 participants
n=941 Participants
|
1 participants
n=59 Participants
|
57 participants
n=1000 Participants
|
|
Region of Enrollment
Italy
|
133 participants
n=941 Participants
|
0 participants
n=59 Participants
|
133 participants
n=1000 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=941 Participants
|
0 participants
n=59 Participants
|
2 participants
n=1000 Participants
|
|
Region of Enrollment
Australia
|
129 participants
n=941 Participants
|
7 participants
n=59 Participants
|
136 participants
n=1000 Participants
|
|
Region of Enrollment
France
|
20 participants
n=941 Participants
|
0 participants
n=59 Participants
|
20 participants
n=1000 Participants
|
|
Region of Enrollment
Lithuania
|
7 participants
n=941 Participants
|
0 participants
n=59 Participants
|
7 participants
n=1000 Participants
|
|
Region of Enrollment
Germany
|
410 participants
n=941 Participants
|
39 participants
n=59 Participants
|
449 participants
n=1000 Participants
|
|
NYHA Classification
NYHA I
|
29 Participants
n=937 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
0 Participants
n=59 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
29 Participants
n=996 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
NYHA Classification
NYHA II
|
309 Participants
n=937 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
16 Participants
n=59 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
325 Participants
n=996 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
NYHA Classification
NYHA III
|
554 Participants
n=937 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
41 Participants
n=59 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
595 Participants
n=996 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
NYHA Classification
NYHA IV
|
45 Participants
n=937 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
2 Participants
n=59 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
47 Participants
n=996 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
PRIMARY outcome
Timeframe: 1 year post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants that died for any reason at 1 year post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With All-cause Mortality
|
12.1 percentage of participants
Interval 10.1 to 14.4
|
—
|
SECONDARY outcome
Timeframe: 30 days through 5 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants that died for any reason at 30 days through 5 years post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With All Cause Mortality in Cohort A
5 years
|
44.3 percentage of participants
|
—
|
|
Percentage of Participants With All Cause Mortality in Cohort A
30 days
|
2.7 percentage of participants
|
—
|
|
Percentage of Participants With All Cause Mortality in Cohort A
1 year
|
12.0 percentage of participants
|
—
|
|
Percentage of Participants With All Cause Mortality in Cohort A
2 years
|
19.5 percentage of participants
|
—
|
|
Percentage of Participants With All Cause Mortality in Cohort A
3 years
|
27.0 percentage of participants
|
—
|
|
Percentage of Participants With All Cause Mortality in Cohort A
4 years
|
35.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 days through 5 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.
Outcome measures
| Measure |
Cohort A
n=59 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B
2 years
|
4 Participants
|
—
|
|
Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B
3 years
|
4 Participants
|
—
|
|
Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B
4 years
|
5 Participants
|
—
|
|
Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B
5 years
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days through 5 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants that died for cardiovascular or unknown reasons as defined by VARC-2 at 30 days through 5 years post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
30 days
|
2.5 percentage of participants
|
—
|
|
Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
1 year
|
6.6 percentage of participants
|
—
|
|
Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
2 year
|
9.8 percentage of participants
|
—
|
|
Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
3 year
|
13.1 percentage of participants
|
—
|
|
Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
4 year
|
18.5 percentage of participants
|
—
|
|
Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
5 year
|
24.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 days through 5 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.
Outcome measures
| Measure |
Cohort A
n=59 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
2 years
|
0 Participants
|
—
|
|
Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
3 years
|
4 Participants
|
—
|
|
Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
4 years
|
2 Participants
|
—
|
|
Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
5 years
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days through 5 years post implantPercentage of participants that died for any reason at 30 days through 5 years post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
30 days
|
0.2 percentage of participants
|
—
|
|
Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
1 year
|
5.8 percentage of participants
|
—
|
|
Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
2 years
|
10.8 percentage of participants
|
—
|
|
Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
3 years
|
16.0 percentage of participants
|
—
|
|
Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
4 years
|
21.1 percentage of participants
|
—
|
|
Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
5 years
|
26.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 days through 5 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.
Outcome measures
| Measure |
Cohort A
n=59 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
2 years
|
1 Participants
|
—
|
|
Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
3 years
|
3 Participants
|
—
|
|
Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
4 years
|
2 Participants
|
—
|
|
Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
5 years
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days through 5 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a myocardial infarction as defined by VARC-2 at 30 days through 5 years post implantation post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
30 days
|
1.6 percentage of participants
|
—
|
|
Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
1 year
|
2.5 percentage of participants
|
—
|
|
Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
2 years
|
3.2 percentage of participants
|
—
|
|
Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
3 years
|
3.6 percentage of participants
|
—
|
|
Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
4 years
|
4.9 percentage of participants
|
—
|
|
Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
5 years
|
6.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 days through 5 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Number of participants with a myocardial infarction as defined by VARC-2 at 30 days through 5 years post implantation post implantation
Outcome measures
| Measure |
Cohort A
n=59 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
2 years
|
0 Participants
|
—
|
|
Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
3 years
|
1 Participants
|
—
|
|
Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
4 years
|
1 Participants
|
—
|
|
Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
5 years
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with vascular access site complication (major or minor) as defined by VARC-2 at 30 days post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Major
|
7.0 percentage of participants
|
—
|
|
Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Minor
|
6.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a bleeding events (life threatening, major or minor) as defined by VARC-2 at 30 days post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Life threatening
|
3.3 percentage of participants
|
—
|
|
Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Major
|
8.3 percentage of participants
|
—
|
|
Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Minor
|
8.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a Stage 1, 2 or Stage 3 acute kidney injury as defined by VARC-2 at 30 days post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Stage 1, 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Stage 1
|
0.4 percentage of participants
|
—
|
|
Percentage of Participants With Stage 1, 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Stage 2
|
1.0 percentage of participants
|
—
|
|
Percentage of Participants With Stage 1, 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Stage 3
|
2.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 days through 5 years post implantPopulation: The data for the number of participants available at the time has been provided. For Cohort A, a total of 941 subjects participated in the study; however, only 574 were available for AVA analysis.
The aortic valve area as interpreted by an independent echocardiographic core laboratory at 30 days through 5 years post implantation
Outcome measures
| Measure |
Cohort A
n=574 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=59 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)
30 days
|
1.78 cm^2
Standard Deviation 0.48
|
NA cm^2
Standard Deviation NA
Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
|
|
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)
1 year
|
1.74 cm^2
Standard Deviation 0.48
|
NA cm^2
Standard Deviation NA
Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
|
|
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)
2 years
|
1.84 cm^2
Standard Deviation 0.57
|
1.88 cm^2
Standard Deviation 0.49
|
|
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)
3 years
|
1.76 cm^2
Standard Deviation 0.53
|
1.76 cm^2
Standard Deviation 0.45
|
|
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)
4 years
|
1.76 cm^2
Standard Deviation 0.57
|
1.88 cm^2
Standard Deviation 0.48
|
|
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)
5 years
|
1.84 cm^2
Standard Deviation 0.47
|
1.74 cm^2
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 30 days through 5 years post implantPopulation: The data for the number of participants available at the time has been provided. For Cohort A, a total of 941 subjects participated in the study; however, only 684 were available for mean aortic gradient analysis.
The mean transvalvular gradient as interpreted by an independent echocardiographic core laboratory at 30 days through 5 years post implantation
Outcome measures
| Measure |
Cohort A
n=684 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=59 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)
30 days
|
8.58 mmHg
Standard Deviation 3.89
|
NA mmHg
Standard Deviation NA
Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
|
|
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)
1 year
|
8.67 mmHg
Standard Deviation 4.11
|
NA mmHg
Standard Deviation NA
Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
|
|
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)
2 years
|
7.81 mmHg
Standard Deviation 3.78
|
8.04 mmHg
Standard Deviation 3.00
|
|
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)
3 years
|
7.61 mmHg
Standard Deviation 4.29
|
7.34 mmHg
Standard Deviation 4.03
|
|
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)
4 years
|
7.99 mmHg
Standard Deviation 4.10
|
7.69 mmHg
Standard Deviation 4.07
|
|
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)
5 years
|
6.69 mmHg
Standard Deviation 3.52
|
6.44 mmHg
Standard Deviation 4.00
|
SECONDARY outcome
Timeframe: 30 days post implantPopulation: The data for the number of participants available at the time has been provided
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Outcome measures
| Measure |
Cohort A
n=808 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=54 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class I
|
298 Participants
|
13 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class II
|
405 Participants
|
35 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class III
|
98 Participants
|
6 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class IV
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 year post implantPopulation: The data for the number of participants available at the time has been provided
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Outcome measures
| Measure |
Cohort A
n=699 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=59 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class I
|
289 Participants
|
23 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class II
|
356 Participants
|
25 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class III
|
51 Participants
|
10 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class IV
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 years post implantPopulation: The data for the number of participants available at the time has been provided
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Outcome measures
| Measure |
Cohort A
n=595 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=46 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class I
|
244 Participants
|
14 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class II
|
283 Participants
|
22 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class III
|
64 Participants
|
10 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class IV
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 years post implantPopulation: The data for the number of participants available at the time has been provided
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Outcome measures
| Measure |
Cohort A
n=509 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=44 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class I
|
194 Participants
|
15 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class II
|
251 Participants
|
19 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class III
|
62 Participants
|
9 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class IV
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 4 years post implantPopulation: The data for the number of participants available at the time has been provided
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Outcome measures
| Measure |
Cohort A
n=423 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=39 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class I
|
147 Participants
|
7 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class II
|
211 Participants
|
26 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class III
|
59 Participants
|
5 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class IV
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 5 years post implantPopulation: The data for the number of participants available at the time has been provided
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Outcome measures
| Measure |
Cohort A
n=345 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=34 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class I
|
113 Participants
|
11 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class II
|
174 Participants
|
14 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class III
|
54 Participants
|
8 Participants
|
|
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Class IV
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days through 5 years post implantPopulation: The data for the number of participants available at the time has been provided. For Cohort A, a total of 941 subjects participated in the study; however, only 569 were available for 6 minute walk test.
Distance in metres that the participant can walk in 6 minutes. The six-minute walking test (6MWT) is a commonly used objective measure of functional exercise capacity in individuals with moderately severe impairment.
Outcome measures
| Measure |
Cohort A
n=569 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=59 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Mean Six Minute Walk Test (6MWT)
30 days
|
276.3 meter
Standard Deviation 117.5
|
250.60 meter
Standard Deviation 104.61
|
|
Mean Six Minute Walk Test (6MWT)
1 year
|
285.75 meter
Standard Deviation 112.12
|
257.18 meter
Standard Deviation 97.96
|
|
Mean Six Minute Walk Test (6MWT)
2 years
|
276.4 meter
Standard Deviation 116.2
|
253.4 meter
Standard Deviation 119.8
|
|
Mean Six Minute Walk Test (6MWT)
3 years
|
283.4 meter
Standard Deviation 119.4
|
244.4 meter
Standard Deviation 111.6
|
|
Mean Six Minute Walk Test (6MWT)
4 years
|
288.4 meter
Standard Deviation 106.2
|
236.4 meter
Standard Deviation 100.0
|
|
Mean Six Minute Walk Test (6MWT)
5 years
|
286.4 meter
Standard Deviation 110.9
|
197.5 meter
Standard Deviation 107.7
|
SECONDARY outcome
Timeframe: 30 days and 1 year post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up. For Cohort A, a total of 941 subjects participated in the study; however, only 774 were available for EQ5D analysis.
EuroQuol-5 Dimensions (EQ5D) is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. This scale ranges between 0-100, where 0 is 'the worst health you can imagine' and 100 is 'the best health you can imagine'.
Outcome measures
| Measure |
Cohort A
n=774 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Mean Quality of Life Assessment in Cohort A
30 days
|
67.3 score on a scale
Standard Deviation 18.0
|
—
|
|
Mean Quality of Life Assessment in Cohort A
1 year
|
68.8 score on a scale
Standard Deviation 17.7
|
—
|
SECONDARY outcome
Timeframe: 30 days through 5 years post implantationPercentage of participants with transient ischemic attack as defined by VARC-2 at 30 days through 5 years post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Transient Ischemic Attack in Cohort A
30 days
|
0.4 percentage of participants
|
—
|
|
Percentage of Participants With Transient Ischemic Attack in Cohort A
1 year
|
1.4 percentage of participants
|
—
|
|
Percentage of Participants With Transient Ischemic Attack in Cohort A
2 years
|
1.9 percentage of participants
|
—
|
|
Percentage of Participants With Transient Ischemic Attack in Cohort A
3 years
|
1.9 percentage of participants
|
—
|
|
Percentage of Participants With Transient Ischemic Attack in Cohort A
4 years
|
2.5 percentage of participants
|
—
|
|
Percentage of Participants With Transient Ischemic Attack in Cohort A
5 years
|
2.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 days through 5 years post implantationPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Number of participants with transient ischemic attack as defined by VARC-2 at 30 days through 5 years post implantation
Outcome measures
| Measure |
Cohort A
n=59 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With Transient Ischemic Attack in Cohort B
2 years
|
1 Participants
|
—
|
|
Number of Participants With Transient Ischemic Attack in Cohort B
3 years
|
0 Participants
|
—
|
|
Number of Participants With Transient Ischemic Attack in Cohort B
4 years
|
0 Participants
|
—
|
|
Number of Participants With Transient Ischemic Attack in Cohort B
5 years
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 30 days post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Disabling
|
1.4 percentage of participants
|
—
|
|
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Non-disabling
|
1.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 year post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 1 year post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Disabling
|
2.1 percentage of participants
|
—
|
|
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Non-disabling
|
2.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 2 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 2 years post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Disabling
|
3.2 percentage of participants
|
—
|
|
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Non-disabling
|
3.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 3 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 3 years post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Disabling
|
4.3 percentage of participants
|
—
|
|
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Non-disabling
|
3.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 4 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 4 years post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Disabling
|
6.3 percentage of participants
|
—
|
|
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Non-disabling
|
4.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 5 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 5 years post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Disabling
|
7.8 percentage of participants
|
—
|
|
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Non-disabling
|
4.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 2 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2year follow-up.
Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 2 years post implantation
Outcome measures
| Measure |
Cohort A
n=59 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Disabling
|
0 Participants
|
—
|
|
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Non-disabling
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2year follow-up.
Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 3 years post implantation
Outcome measures
| Measure |
Cohort A
n=59 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Disabling
|
0 Participants
|
—
|
|
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Non-disabling
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2year follow-up.
Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 4 years post implantation
Outcome measures
| Measure |
Cohort A
n=59 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Disabling
|
0 Participants
|
—
|
|
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Non-disabling
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 5 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2year follow-up.
Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 5 years post implantation
Outcome measures
| Measure |
Cohort A
n=59 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Disabling
|
0 Participants
|
—
|
|
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Non-disabling
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 30 days post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
New-onset atrial fibrillation
|
4.0 percentage of participants
|
—
|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
New pacemaker implant in pacemaker naïve patients
|
19.0 percentage of participants
|
—
|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Overall PM implantation
|
17.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 year post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 1 year post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
New-onset atrial fibrillation
|
5.3 percentage of participants
|
—
|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
New pacemaker implant in pacemaker naïve patients
|
21.2 percentage of participants
|
—
|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Overall PM implantation
|
19.4 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 2 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 2 years post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
New-onset atrial fibrillation
|
5.9 percentage of participants
|
—
|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
New pacemaker implant in pacemaker naïve patients
|
22.4 percentage of participants
|
—
|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Overall PM implantation
|
20.4 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 3 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 3 years post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
New-onset atrial fibrillation
|
7.3 percentage of participants
|
—
|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
New pacemaker implant in pacemaker naïve patients
|
23.6 percentage of participants
|
—
|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Overall PM implantation
|
21.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 4 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 4 years post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
New-onset atrial fibrillation
|
8.8 percentage of participants
|
—
|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
New pacemaker implant in pacemaker naïve patients
|
25.4 percentage of participants
|
—
|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Overall PM implantation
|
23.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 5 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 5 years post implantation
Outcome measures
| Measure |
Cohort A
n=941 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
New-onset atrial fibrillation
|
9.5 percentage of participants
|
—
|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
New pacemaker implant in pacemaker naïve patients
|
27.7 percentage of participants
|
—
|
|
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Overall PM implantation
|
25.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 2 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 2 years post implantation
Outcome measures
| Measure |
Cohort A
n=59 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
New-onset atrial fibrillation
|
1 Participants
|
—
|
|
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
New pacemaker implant in pacemaker naïve patients
|
1 Participants
|
—
|
|
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Overall PM implantation
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 3 years post implantation
Outcome measures
| Measure |
Cohort A
n=59 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
New pacemaker implant in pacemaker naïve patients
|
0 Participants
|
—
|
|
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
New-onset atrial fibrillation
|
0 Participants
|
—
|
|
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Overall PM implantation
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 4 years post implantation
Outcome measures
| Measure |
Cohort A
n=59 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
New-onset atrial fibrillation
|
2 Participants
|
—
|
|
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
New pacemaker implant in pacemaker naïve patients
|
0 Participants
|
—
|
|
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Overall PM implantation
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 5 years post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 5 years post implantation
Outcome measures
| Measure |
Cohort A
n=59 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
New-onset atrial fibrillation
|
1 Participants
|
—
|
|
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
New pacemaker implant in pacemaker naïve patients
|
0 Participants
|
—
|
|
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Overall PM implantation
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 30 days post implantation
Outcome measures
| Measure |
Cohort A
n=689 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
None/trace/trivial
|
28.4 percentage of participants
|
—
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
Mild
|
67.6 percentage of participants
|
—
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
Moderate
|
3.9 percentage of participants
|
—
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
Severe
|
0.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 year post implantPopulation: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 1 year post implantation
Outcome measures
| Measure |
Cohort A
n=575 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
None/trace/trivial
|
29.7 percentage of participants
|
—
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
Mild
|
67.7 percentage of participants
|
—
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
Moderate
|
2.6 percentage of participants
|
—
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
Severe
|
0.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 2 years post implantPercentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 2 years post implantation
Outcome measures
| Measure |
Cohort A
n=344 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=40 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
None/trace/trivial
|
56.1 percentage of participants
|
57.5 percentage of participants
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Mild
|
42.4 percentage of participants
|
42.5 percentage of participants
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Moderate
|
1.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 3 years post implantPercentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 3 years post implantation
Outcome measures
| Measure |
Cohort A
n=248 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=34 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
None/trace/trivial
|
64.9 percentage of participants
|
70.6 percentage of participants
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Mild
|
34.7 percentage of participants
|
29.4 percentage of participants
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Moderate
|
0.4 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 4 years post implantPercentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 4 years post implantation
Outcome measures
| Measure |
Cohort A
n=188 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=28 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
None/trace/trivial
|
53.2 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Mild
|
45.7 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Moderate
|
1.1 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 5 years post implantPercentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 5 years post implantation
Outcome measures
| Measure |
Cohort A
n=182 Participants
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=23 Participants
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
None/trace/trivial
|
69.8 percentage of participants
|
69.6 percentage of participants
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Mild
|
28.6 percentage of participants
|
30.4 percentage of participants
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Moderate
|
1.6 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Cohort A
Serious events: 754 serious events
Other events: 526 other events
Deaths: 382 deaths
Cohort B
Serious events: 40 serious events
Other events: 22 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Cohort A
n=941 participants at risk
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=59 participants at risk
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Clinical significant bleeding
|
7.1%
67/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
5.1%
3/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Blood and lymphatic system disorders
Life threatening bleeding
|
3.3%
31/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Blood and lymphatic system disorders
Major bleeding
|
7.9%
74/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Blood and lymphatic system disorders
Minor bleeding
|
1.6%
15/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Blood and lymphatic system disorders
Not clinical significant bleeding
|
1.8%
17/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
1.7%
1/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
Arrhythmia / Conduction abnormality
|
27.2%
256/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
5.1%
3/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
Coronary obstruction
|
0.11%
1/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
Endocarditis
|
0.74%
7/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
New Onset of Atrial Fibrillation
|
2.7%
25/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
1.7%
1/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
Peri-Procedural MI
|
1.2%
11/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
Prosthetic aortic valve regurgitation
|
0.74%
7/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
Prosthetic aortic valve stenosis
|
0.21%
2/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
Spontaneous MI
|
3.6%
34/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
3.4%
2/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
General disorders
Disabling stroke
|
5.6%
53/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
General disorders
Non-Disabling stroke
|
3.7%
35/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
General disorders
Other
|
63.4%
597/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
55.9%
33/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
General disorders
TIA
|
1.8%
17/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
1.7%
1/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Renal and urinary disorders
Stage 1 AKI
|
0.64%
6/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Renal and urinary disorders
Stage 2 AKI
|
0.85%
8/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Renal and urinary disorders
Stage 3 AKI
|
4.1%
39/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Renal and urinary disorders
Undetermined AKI
|
1.4%
13/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
3.4%
2/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Surgical and medical procedures
Need for second TAVI
|
0.85%
8/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Surgical and medical procedures
Pacemaker implantation
|
21.7%
204/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
1.7%
1/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Vascular disorders
Major vascular complications
|
6.9%
65/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Vascular disorders
Minor vascular complications
|
1.5%
14/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
Other adverse events
| Measure |
Cohort A
n=941 participants at risk
Patients implanted with a Portico valve after CE mark
|
Cohort B
n=59 participants at risk
Patients implanted in previous SJM-sponsored premarket studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Clinical significant bleeding
|
0.32%
3/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Blood and lymphatic system disorders
Life threatening bleeding
|
0.11%
1/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Blood and lymphatic system disorders
Major bleeding
|
0.53%
5/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Blood and lymphatic system disorders
Minor bleeding
|
7.3%
69/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Blood and lymphatic system disorders
Not clinical significant bleeding
|
0.74%
7/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
Endocarditis
|
0.32%
3/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
New Onset of Atrial Fibrillation
|
5.3%
50/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
5.1%
3/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
Peri-Procedural MI
|
0.21%
2/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
Prosthetic aortic valve regurgitation
|
2.9%
27/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
Prosthetic aortic valve stenosis
|
0.64%
6/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Cardiac disorders
Arrhythmia / Conduction abnormality
|
30.2%
284/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
8.5%
5/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
General disorders
Other
|
33.2%
312/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
28.8%
17/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
General disorders
TIA
|
0.53%
5/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Renal and urinary disorders
Stage 1 AKI
|
0.32%
3/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Renal and urinary disorders
Stage 2 AKI
|
0.21%
2/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
1.7%
1/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Renal and urinary disorders
Stage 3 AKI
|
0.21%
2/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Renal and urinary disorders
Undetermined AKI
|
0.53%
5/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Surgical and medical procedures
Need for second TAVI
|
0.53%
5/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Surgical and medical procedures
Pacemaker implantation
|
0.85%
8/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Vascular disorders
Major vascular complications
|
0.21%
2/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Vascular disorders
Minor vascular complications
|
4.8%
45/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
|
Vascular disorders
Undetermined vascular complications
|
0.21%
2/941 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
0.00%
0/59 • 5 Year
The 5-year KM rate of all-cause mortality is estimated on exact 1826 days post procedure, so 366 are the # of death happened before this time. In the withdrawal table, the # of death, 382, are counted based on visit window of the 5 years visit. If a subject missed 5 years visit and the death happened before the upper window of 5 years visit, the death will be counted. So normally the withdrawal table will show more death than the KM rate table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60