Trial Outcomes & Findings for On-X Heart Valve - 17mm Aortic and 23mm Mitral (NCT NCT01812174)
NCT ID: NCT01812174
Last Updated: 2024-03-06
Results Overview
Number of subjects with a valve related adverse event at 1 year.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
1 Year
Results posted on
2024-03-06
Participant Flow
Participant milestones
| Measure |
17mm On-X Aortic Heart Valve
Patients receiving the 17mm On-X aortic heart valve as a replacement for diseased native or prosthetic aortic heart valve.
17mm aortic valve (On-X ): Heart aortic valve replacement surgery: 17mm Aortic
|
23mm On-X Mitral Heart Valve
Patients receiving the 23mm On-X mitral heart valve as a replacement for diseased native or prosthetic mitral heart valve.
23mm mitral valve (On-X): Heart mitral valve replacement surgery: 23mm Mitral
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
6
|
|
Overall Study
COMPLETED
|
11
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
17mm On-X Aortic Heart Valve
Patients receiving the 17mm On-X aortic heart valve as a replacement for diseased native or prosthetic aortic heart valve.
17mm aortic valve (On-X ): Heart aortic valve replacement surgery: 17mm Aortic
|
23mm On-X Mitral Heart Valve
Patients receiving the 23mm On-X mitral heart valve as a replacement for diseased native or prosthetic mitral heart valve.
23mm mitral valve (On-X): Heart mitral valve replacement surgery: 23mm Mitral
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
17mm On-X Aortic Heart Valve
n=14 Participants
Patients receiving the 17mm On-X aortic heart valve as a replacement for diseased native or prosthetic aortic heart valve.
17mm aortic valve (On-X ): Heart aortic valve replacement surgery: 17mm Aortic
|
23mm On-X Mitral Heart Valve
n=6 Participants
Patients receiving the 23mm On-X mitral heart valve as a replacement for diseased native or prosthetic mitral heart valve.
23mm mitral valve (On-X): Heart mitral valve replacement surgery: 23mm Mitral
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=14 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=14 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=14 Participants
|
0 Participants
n=6 Participants
|
10 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=14 Participants
|
3 Participants
n=6 Participants
|
14 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=14 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Puerto Rico
|
5 participants
n=14 Participants
|
0 participants
n=6 Participants
|
5 participants
n=20 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=14 Participants
|
6 participants
n=6 Participants
|
10 participants
n=20 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=14 Participants
|
0 participants
n=6 Participants
|
5 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 1 YearPopulation: All adverse events for all enrolled subjects, regardless of study completion are counted.
Number of subjects with a valve related adverse event at 1 year.
Outcome measures
| Measure |
17mm On-X Aortic Heart Valve
n=14 Participants
Patients receiving the 17mm On-X aortic heart valve as a replacement for diseased native or prosthetic aortic heart valve.
17mm aortic valve (On-X ): Heart aortic valve replacement surgery: 17mm Aortic
|
23mm On-X Mitral Heart Valve
n=6 Participants
Patients receiving the 23mm On-X mitral heart valve as a replacement for diseased native or prosthetic mitral heart valve.
23mm mitral valve (On-X): Heart mitral valve replacement surgery: 23mm Mitral
|
|---|---|---|
|
Number of Valve Related Adverse Events at 1 Year
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1-yearPopulation: Only subjects that completed the 1 year follow up were included in this analysis.
Number of subjects with a diagnosis of Valve Thrombosis at 1 year
Outcome measures
| Measure |
17mm On-X Aortic Heart Valve
n=11 Participants
Patients receiving the 17mm On-X aortic heart valve as a replacement for diseased native or prosthetic aortic heart valve.
17mm aortic valve (On-X ): Heart aortic valve replacement surgery: 17mm Aortic
|
23mm On-X Mitral Heart Valve
n=6 Participants
Patients receiving the 23mm On-X mitral heart valve as a replacement for diseased native or prosthetic mitral heart valve.
23mm mitral valve (On-X): Heart mitral valve replacement surgery: 23mm Mitral
|
|---|---|---|
|
Diagnosis of Valve Thrombosis at 1 Year
|
0 Participants
|
0 Participants
|
Adverse Events
17mm On-X Aortic Heart Valve
Serious events: 6 serious events
Other events: 0 other events
Deaths: 2 deaths
23mm On-X Mitral Heart Valve
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
17mm On-X Aortic Heart Valve
n=14 participants at risk
Patients receiving the 17mm On-X aortic heart valve as a replacement for diseased native or prosthetic aortic heart valve.
17mm aortic valve (On-X ): Heart aortic valve replacement surgery: 17mm Aortic
|
23mm On-X Mitral Heart Valve
n=6 participants at risk
Patients receiving the 23mm On-X mitral heart valve as a replacement for diseased native or prosthetic mitral heart valve.
23mm mitral valve (On-X): Heart mitral valve replacement surgery: 23mm Mitral
|
|---|---|---|
|
Cardiac disorders
Permanent Pacemaker Implant
|
14.3%
2/14 • Number of events 2 • Adverse event data was collected from time of implant up to 1 year post implant.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected from time of implant up to 1 year post implant.
|
|
Injury, poisoning and procedural complications
Dislocation of Right Temporomandibular joint
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected from time of implant up to 1 year post implant.
|
0.00%
0/6 • Adverse event data was collected from time of implant up to 1 year post implant.
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
14.3%
2/14 • Number of events 2 • Adverse event data was collected from time of implant up to 1 year post implant.
|
0.00%
0/6 • Adverse event data was collected from time of implant up to 1 year post implant.
|
|
Surgical and medical procedures
Bleed- Major
|
14.3%
2/14 • Number of events 4 • Adverse event data was collected from time of implant up to 1 year post implant.
|
0.00%
0/6 • Adverse event data was collected from time of implant up to 1 year post implant.
|
|
Infections and infestations
Septic Shock
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected from time of implant up to 1 year post implant.
|
0.00%
0/6 • Adverse event data was collected from time of implant up to 1 year post implant.
|
|
Cardiac disorders
Congestive Heart Failure
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected from time of implant up to 1 year post implant.
|
0.00%
0/6 • Adverse event data was collected from time of implant up to 1 year post implant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Failure
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected from time of implant up to 1 year post implant.
|
0.00%
0/6 • Adverse event data was collected from time of implant up to 1 year post implant.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All information which I hereafter obtain from ON-X LIFE TECHNOLOGIES … about or relating to the prosthesis … which is the subject of this study and all information which I have … concerning this study is considered by ON-X to be proprietary and confidential to ON-X .I … will not use such confidential information, or release, reveal or disclose such confidential information to anyone without the written consent of ON-X or prior public disclosure by ON-X.
- Publication restrictions are in place
Restriction type: OTHER