Trial Outcomes & Findings for Hemodynamic Comparison of Tissue Aortic Valves (NCT NCT01635244)
NCT ID: NCT01635244
Last Updated: 2017-02-03
Results Overview
This is a measure of the resistance to flow across the aortic bioprosthesis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
6 months after aortic valve replacement
Results posted on
2017-02-03
Participant Flow
Participant milestones
| Measure |
Freestyle
Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
|
Magna Ease
Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
|
Trifecta
Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
22
|
20
|
|
Overall Study
COMPLETED
|
17
|
21
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hemodynamic Comparison of Tissue Aortic Valves
Baseline characteristics by cohort
| Measure |
Freestyle
n=17 Participants
Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
|
Magna Ease
n=21 Participants
Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
|
Trifecta
n=18 Participants
Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
74 years
n=5 Participants
|
67 years
n=7 Participants
|
71 years
n=5 Participants
|
70 years
n=4 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Gender
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
18 participants
n=5 Participants
|
56 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 months after aortic valve replacementThis is a measure of the resistance to flow across the aortic bioprosthesis.
Outcome measures
| Measure |
Freestyle
n=17 Participants
Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
|
Magna Ease
n=21 Participants
Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
|
Trifecta
n=18 Participants
Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).
Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
|
|---|---|---|---|
|
Aortic Valve Mean Gradient (mm Hg) at Peak Exercise
|
11 mm Hg
Interval 8.0 to 16.0
|
14 mm Hg
Interval 11.0 to 17.0
|
11 mm Hg
Interval 8.0 to 13.0
|
Adverse Events
Freestyle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Magna Ease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trifecta
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place