Heart Valve Disease
Conditions
Keywords
heart valve
Brief summary
This study examines the hemodynamic and hemolytic properties of two additional smaller size valves to the On-X line of valves already approved by FDA.
Detailed description
The purpose of the study is to assess the safety and efficacy of the 17mm On-X Aortic Prosthetic Heart Valve and the 23mm On-X Mitral Prosthetic Heart Valve when used to replace diseased aortic or mitral valves in human subjects. The On-X 17mm aortic valve will be implanted in approximately 20 and at least 15 patients who will be followed for at least 1 year. Patients will be any age and will require this size valve as determined in surgery but will be recruited prior to surgery based on results of preoperative screening tests. Enrollment into the 23mm mitral arm of the study has been terminated.
Interventions
DEVICE17mm aortic valve (On-X )
Heart aortic valve replacement surgery: 17mm Aortic
DEVICE23mm mitral valve (On-X)
Heart mitral valve replacement surgery: 23mm Mitral
Sponsors
On-X Life Technologies, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients in one arm are recipients of the 17mm On-X Aortic Valve. Patients in the second arm are recipients of the 23mm On-X Mitral Valve. Since double valve cases are exclusionary, these two arms are mutually exclusive and non-randomized.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients of any age; unless waived by local IRB assent of the patient and in all cases consent of parent or legally authorized representative is required if a patient is under the age of majority and not legally emancipated. 2. Patients who are sufficiently ill to warrant replacement of their diseased natural or prosthetic valve, based on standard cardiovascular diagnostic workups. 3. Patients who are in sufficient satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk, (i.e., likely to survive one year postoperatively). 4. Patients who require an isolated aortic valve replacement size 17 mm or isolated mitral valve replacement size 23mm. 5. Patients who are geographically stable and willing to return to the implanting center for follow-up visits. 6. Patients or legally authorized representatives who are adequately informed of their participation in the clinical study and what will be required of them in order to comply with the protocol. 7. Patients requiring concomitant cardiovascular surgery, such as coronary bypass may be included in the study.
Exclusion criteria
1\. Patients who are pregnant, planning to become pregnant or are lactating. 2 Patients who have a noncardiac progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient. 3 Patients who have a documented history of substance (drug or alcohol) abuse or are prison inmates. 4\. Patients with a previous prosthetic valve, where it is not being replaced by a study valve, or patients requiring multiple valve replacement. 5\. Patients with active endocarditis or active myocarditis. 6 Patients who require tricuspid or pulmonic valve replacement. 7. Patients who have not agreed to return for the required number of follow-up visits or who are geographically unavailable for follow-up. 8\. Patients who cannot be maintained on long-term anticoagulant therapy. 9. Patients with non-cardiac illness resulting in a life expectancy of less than 1-year. 10\. Patients previously enrolled and implanted in this trial may not re-enter after withdrawal. 11\. Patients already enrolled in another investigational device or drug study (nor can enrolled patients be enrolled in other studies). 12\. Patients with acute preoperative neurological deficit, myocardial infarction, or cardiac event who have not returned to baseline for at least 30-days prior to enrollment. 13\. Patients with aortic aneurysm or other medical condition that creates a higher than usual risk of surgical complication. 14\. Patients who are prisoners or mentally ill, and pediatric patients who are incapable of understanding their assent as judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Valve Related Adverse Events at 1 Year | 1 Year | Number of subjects with a valve related adverse event at 1 year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of Valve Thrombosis at 1 Year | 1-year | Number of subjects with a diagnosis of Valve Thrombosis at 1 year |
Countries
Puerto Rico, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 14 |
| 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 | 6 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 0 |
Baseline characteristics
| Characteristic | 17mm On-X Aortic Heart Valve | 23mm On-X Mitral Heart Valve | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 5 Participants | 7 Participants |
| Age, Categorical >=65 years | 10 Participants | 0 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Puerto Rico | 5 participants | 0 participants | 5 participants |
| Region of Enrollment Spain | 5 participants | 0 participants | 5 participants |
| Region of Enrollment United States | 4 participants | 6 participants | 10 participants |
| Sex: Female, Male Female | 11 Participants | 3 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 14 | 0 / 6 |
| other Total, other adverse events | 0 / 14 | 0 / 6 |
| serious Total, serious adverse events | 6 / 14 | 1 / 6 |
Outcome results
Primary
Number of Valve Related Adverse Events at 1 Year
Number of subjects with a valve related adverse event at 1 year.
Time frame: 1 Year
Population: All adverse events for all enrolled subjects, regardless of study completion are counted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17mm On-X Aortic Heart Valve | Number of Valve Related Adverse Events at 1 Year | 0 Participants |
| 23mm On-X Mitral Heart Valve | Number of Valve Related Adverse Events at 1 Year | 0 Participants |
Secondary
Diagnosis of Valve Thrombosis at 1 Year
Number of subjects with a diagnosis of Valve Thrombosis at 1 year
Time frame: 1-year
Population: Only subjects that completed the 1 year follow up were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 17mm On-X Aortic Heart Valve | Diagnosis of Valve Thrombosis at 1 Year | 0 Participants |
| 23mm On-X Mitral Heart Valve | Diagnosis of Valve Thrombosis at 1 Year | 0 Participants |