Trial Outcomes & Findings for CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis. (NCT NCT03752866)
NCT ID: NCT03752866
Last Updated: 2024-10-21
Results Overview
Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1001 participants
Primary outcome timeframe
30 days from the index procedure
Results posted on
2024-10-21
Participant Flow
Between October 2018 and July 2021, implantation with a Portico™ transcatheter heart valve (THV) was attempted in 1001 subjects. This clinical investigation includes 27 sites in 8 countries across Europe and 1 site in Australia.
Participant milestones
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Overall Study
STARTED
|
501
|
500
|
|
Overall Study
COMPLETED
|
501
|
500
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
Total
n=1001 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
81.7 years
STANDARD_DEVIATION 5.4 • n=501 Participants
|
82.3 years
STANDARD_DEVIATION 5.3 • n=500 Participants
|
82.0 years
STANDARD_DEVIATION 5.3 • n=1001 Participants
|
|
Sex: Female, Male
Female
|
319 Participants
n=501 Participants
|
307 Participants
n=500 Participants
|
626 Participants
n=1001 Participants
|
|
Sex: Female, Male
Male
|
182 Participants
n=501 Participants
|
193 Participants
n=500 Participants
|
375 Participants
n=1001 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
4 Participants
n=501 Participants
|
0 Participants
n=500 Participants
|
4 Participants
n=1001 Participants
|
|
Region of Enrollment
Czechia
|
25 Participants
n=501 Participants
|
42 Participants
n=500 Participants
|
67 Participants
n=1001 Participants
|
|
Region of Enrollment
Poland
|
10 Participants
n=501 Participants
|
24 Participants
n=500 Participants
|
34 Participants
n=1001 Participants
|
|
Region of Enrollment
Italy
|
43 Participants
n=501 Participants
|
68 Participants
n=500 Participants
|
111 Participants
n=1001 Participants
|
|
Region of Enrollment
United Kingdom
|
44 Participants
n=501 Participants
|
25 Participants
n=500 Participants
|
69 Participants
n=1001 Participants
|
|
Region of Enrollment
Australia
|
20 Participants
n=501 Participants
|
8 Participants
n=500 Participants
|
28 Participants
n=1001 Participants
|
|
Region of Enrollment
Switzerland
|
12 Participants
n=501 Participants
|
0 Participants
n=500 Participants
|
12 Participants
n=1001 Participants
|
|
Region of Enrollment
Germany
|
272 Participants
n=501 Participants
|
195 Participants
n=500 Participants
|
467 Participants
n=1001 Participants
|
|
Region of Enrollment
Spain
|
71 Participants
n=501 Participants
|
138 Participants
n=500 Participants
|
209 Participants
n=1001 Participants
|
|
Hypertension
|
440 Participants
n=501 Participants
|
431 Participants
n=500 Participants
|
871 Participants
n=1001 Participants
|
|
NYHA Classification
NYHA I
|
14 Participants
n=501 Participants
|
4 Participants
n=500 Participants
|
18 Participants
n=1001 Participants
|
|
NYHA Classification
NYHA II
|
160 Participants
n=501 Participants
|
185 Participants
n=500 Participants
|
345 Participants
n=1001 Participants
|
|
NYHA Classification
NYHA III
|
295 Participants
n=501 Participants
|
293 Participants
n=500 Participants
|
588 Participants
n=1001 Participants
|
|
NYHA Classification
NYHA IV
|
32 Participants
n=501 Participants
|
18 Participants
n=500 Participants
|
50 Participants
n=1001 Participants
|
|
Baseline EQ5D-3L Visual Analog Scale Value
|
60.8 units on a scale
STANDARD_DEVIATION 18.5 • n=406 Participants • The number analyzed in row differs because not all subjects had EQ5D-3L collected at baseline.
|
60.1 units on a scale
STANDARD_DEVIATION 17.8 • n=458 Participants • The number analyzed in row differs because not all subjects had EQ5D-3L collected at baseline.
|
60.4 units on a scale
STANDARD_DEVIATION 18.1 • n=864 Participants • The number analyzed in row differs because not all subjects had EQ5D-3L collected at baseline.
|
PRIMARY outcome
Timeframe: 30 days from the index procedurePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause.
Outcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Cardiovascular Mortality
|
15 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At 30 daysOutcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Number of Subjects With Myocardial Infarction
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At 30 daysOutcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Number of Subjects With Stroke
Disabling Stroke
|
8 Participants
|
10 Participants
|
|
Number of Subjects With Stroke
Non-Disabling Stroke
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At 30 daysOutcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Number of Subjects With Bleeding Events
Life Threatening
|
16 Participants
|
18 Participants
|
|
Number of Subjects With Bleeding Events
Major
|
26 Participants
|
33 Participants
|
|
Number of Subjects With Bleeding Events
Minor
|
31 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: At 30 daysThe increase in creatinine must occur within 48 hours. Stage 1: Increase in serum creatinine to 150% to 199% (1.5 to 1.99 X increase compared with baseline) or increase of greater than or equal to 0.3 mg/dL (26.4 mmol/L) or Urine output \<0.5 mL/kg per hour for \>6 but \<12 hours. Stage 2: Increase in serum creatinine to 200% to 299% (2.0 to 2.99 X increase compared with baseline) or Urine output \<0.5 mL/kg per hour for \>12 but \<24 hours. Stage 3: Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output \<0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.
Outcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Number of Subjects With Acute Kidney Injury
Stage 1
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Acute Kidney Injury
Stage 2
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Acute Kidney Injury
Stage 3
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At 30 daysOutcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Number of Subjects With Vascular Complications
Major
|
32 Participants
|
41 Participants
|
|
Number of Subjects With Vascular Complications
Minor
|
36 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: At 30 daysOutcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Number of Subjects With Annular Rupture
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At 30 daysOutcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Number of Subjects With Coronary Obstruction
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At 30 daysOutcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Number of Subjects Undergoing Conversion To Open Surgery
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At 30 daysOutcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At 30 daysOutcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Number Of Subjects With Valve Embolization
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: At 30 daysPopulation: Subjects with a pacemaker at baseline are not included.
Outcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=454 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=444 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion
|
87 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: At 30 daysOutcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=499 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=497 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Vessel Diameter
|
7.42 mm
Standard Deviation 1.44
|
7.09 mm
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: At 30 daysThis is a yes or no question on the CRF. Sites report if the implanter used an introducer sheath (a special device used to facilitate introduction of the investigational device into the subjects vasculature).
Outcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Introducer Sheath Used
|
469 Participants
|
120 Participants
|
SECONDARY outcome
Timeframe: At 30 daysOutcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Implant Success
|
488 Participants
|
488 Participants
|
SECONDARY outcome
Timeframe: At 30 daysEffective orifice area is a measure of the working area of the implanted valve determined by echocardiograph.
Outcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=320 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=283 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Effective Orifice Area
|
1.85 cm^2
Standard Deviation 0.48
|
1.80 cm^2
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: At 30 daysAortic valve mean gradient is a measure of the pressure gradient across the aortic valve measured by echocardiograph.
Outcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=404 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=405 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Aortic Valve Mean Gradient
|
7.38 mmHg
Standard Deviation 4.44
|
6.80 mmHg
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: At 30 daysOutcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=382 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=386 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Number of Subjects With Paravalvular Leak (PVL)
Severe
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Paravalvular Leak (PVL)
None/Trace/Trivial
|
185 Participants
|
158 Participants
|
|
Number of Subjects With Paravalvular Leak (PVL)
Mild
|
188 Participants
|
221 Participants
|
|
Number of Subjects With Paravalvular Leak (PVL)
Moderate
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: At 30 daysNYHA Functional Classification is a system used to assess patient heart failure severity based on their limitations of physical activity. The four classes are described below: Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. Subjects' NYHA Classification based on above criteria was assessed during follow up, and subjects were assigned to one of four classifications. Results are presented as percentage of all available subjects who were assigned each functional class (I-IV).
Outcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=431 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=457 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
NYHA Classification
NYHA I
|
152 Participants
|
159 Participants
|
|
NYHA Classification
NYHA II
|
218 Participants
|
254 Participants
|
|
NYHA Classification
NYHA III
|
58 Participants
|
42 Participants
|
|
NYHA Classification
NYHA IV
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 30 daysThe EQ-5D-3L consists of EuroQoL 5 questions and 3 answering levels. The rating of questions includes: Level 1 no problems; Level 2 some problems; Level 3 Significant problems; Worst case is 15 points; and best case is 5 points using index. The Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state."
Outcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=406 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=458 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
EQ5D-3L Visual Analog Scale Value
|
66.5 units on a scale
Standard Deviation 18.3
|
66.0 units on a scale
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: At 12 monthsKaplan-Meier (KM) percentage of subjects who died. KM is a statistical method that attempts to account for other factors that may have reduced the number of subjects evaluable at a given time point.
Outcome measures
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 Participants
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 Participants
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Kaplan-Meier Rate of All-cause Mortality
|
13.7 percentage of All-cause Mortality
|
11.0 percentage of All-cause Mortality
|
Adverse Events
Portico™ Valve, Delivery System(s) and Loading System(s)
Serious events: 348 serious events
Other events: 72 other events
Deaths: 16 deaths
Portico™ Valve, FlexNav Delivery and Loading System(s)
Serious events: 358 serious events
Other events: 80 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 participants at risk
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 participants at risk
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
12/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
2.4%
12/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Blood and lymphatic system disorders
Other
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.60%
3/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
1.0%
5/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Blood and lymphatic system disorders
Thrombus
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Aortic Valve Regurgitation
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.60%
3/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
7/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
2.4%
12/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Atrial Flutter
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Bleeding
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Bradycardia
|
0.80%
4/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.80%
4/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Cardiac Arrhythmias
|
1.2%
6/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
1.8%
9/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.80%
4/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Complete Heart Block
|
11.8%
59/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
9.8%
49/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Congestive Heart Failure
|
2.0%
10/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
3.0%
15/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Death - Unknown
|
3.6%
18/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
3.2%
16/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Dyspnea
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.60%
3/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Endocarditis
|
0.80%
4/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.40%
2/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
First Degree Heart Block
|
0.60%
3/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.40%
2/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Left Bundle Branch Block
|
2.6%
13/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
1.8%
9/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Mitral Valve Insufficiency
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.60%
3/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Myocardial Infarction
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.80%
4/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Myocardial Ischemia
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Other
|
6.8%
34/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
6.4%
32/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Paravalvular Leak
|
1.00%
5/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.40%
2/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.60%
3/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Pericardial Tamponade
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.60%
3/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Pleural Effusion
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Respiratory Failure
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Second Degree Heart Block
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.40%
2/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Thrombus On Device
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Valve Embolization
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Endocrine disorders
Other
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Gastrointestinal disorders
Anemia
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Gastrointestinal disorders
GI Bleed
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.40%
2/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Gastrointestinal disorders
Ischemia
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Gastrointestinal disorders
Other
|
0.60%
3/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.60%
3/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Gastrointestinal disorders
Weakness
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
General disorders
Death - Unknown
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.60%
3/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
General disorders
Fever
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
General disorders
Multi Organ Failure
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
General disorders
Other
|
0.60%
3/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.40%
2/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Hepatobiliary disorders
Other
|
0.60%
3/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Infections and infestations
Death - Unknown
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.40%
2/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Infections and infestations
Dyspnea
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Infections and infestations
Fever
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Infections and infestations
Infection
|
2.2%
11/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
4.2%
21/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Infections and infestations
Multi Organ Failure
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Infections and infestations
Other
|
2.0%
10/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
1.8%
9/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Infections and infestations
Renal Insufficiency/Worsening Renal Function
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Infections and infestations
Sepsis
|
1.00%
5/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.80%
4/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Infections and infestations
Urinary Tract Infection/UTI
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.60%
3/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Injury, poisoning and procedural complications
Annulus Rupture
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Injury, poisoning and procedural complications
Valve Embolization
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.60%
3/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Injury, poisoning and procedural complications
Valve Migration
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.60%
3/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Metabolism and nutrition disorders
Other
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Other
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.40%
2/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Unknown
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Nervous system disorders
Death - Unknown
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.40%
2/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Nervous system disorders
Other
|
1.2%
6/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
1.6%
8/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Nervous system disorders
Stroke
|
2.8%
14/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
3.2%
16/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Psychiatric disorders
Other
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.00%
5/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
1.0%
5/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Renal and urinary disorders
Multi Organ Failure
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Renal and urinary disorders
Other
|
1.00%
5/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Renal and urinary disorders
Renal Failure
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
1.0%
5/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Renal and urinary disorders
Renal Insufficiency/Worsening Renal Function
|
1.2%
6/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.60%
3/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Reproductive system and breast disorders
Other
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.40%
2/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.80%
4/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Skin and subcutaneous tissue disorders
Other
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.40%
2/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Surgical and medical procedures
Other
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Vascular disorders
Access Site Bleeding Event
|
0.80%
4/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
1.6%
8/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Vascular disorders
Bleeding
|
2.8%
14/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
2.4%
12/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Vascular disorders
Death - Unknown
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Vascular disorders
Hematoma
|
0.80%
4/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.40%
2/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.60%
3/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Vascular disorders
Ischemia
|
0.20%
1/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Vascular disorders
Other
|
1.6%
8/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.80%
4/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Vascular disorders
Pseudoaneurysm
|
0.60%
3/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.80%
4/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Vascular disorders
Vascular Access Site And Access Related Complications
|
0.80%
4/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
1.2%
6/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Vascular disorders
Vascular Perforation
|
0.80%
4/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Vascular disorders
Vascular Stenosis
|
0.40%
2/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.20%
1/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
|
Vascular disorders
Vessel Occlusion
|
0.80%
4/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
0.00%
0/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
Other adverse events
| Measure |
Portico™ Valve, Delivery System(s) and Loading System(s)
n=501 participants at risk
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
|
Portico™ Valve, FlexNav Delivery and Loading System(s)
n=500 participants at risk
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
|
|---|---|---|
|
Cardiac disorders
Left Bundle Branch Block
|
14.4%
72/501 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
16.0%
80/500 • 30 days
The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.
|
Additional Information
Vinny Podichetty, Sr. Director, Global Clinical Affairs
Abbott
Phone: +1 408-845-1639
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60