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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P000037 S030/ PAS001 |
| Date Original Protocol Accepted |
06/19/2015
|
| Date Current Protocol Accepted |
08/15/2019
|
| Study Name |
Newly Enrolled On-X PAS
|
| Device Name |
ON-X PROSTHETIC HEART VALVE
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
To assess the occurrence of bleeding, valve related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a 5-year follow-up period.
The study is a prospective, multicenter, observational single arm study of newly enrolled patients treated with the On-X Aortic Prosthetic Heart Valve.
|
| Study Population |
1. Adult patients (age 18 years or older) who have an isolated On-X aortic prosthetic heart valve implant and agreed to participate in the registry.
2. Life expectancy of at least 5 years.
3. Patients whose operation occurred within the year prior to recruitment.
The following are criteria for exclusion of patients from this study:
1. Patients having any other type of prosthetic valve implant (isolated or in combination with another valve(s)) or any On- X mitral valve; i.e. no mitral or multiple valve implants.
2. Patients with a prior history of arterial thromboembolic events, or who have such events prior to recruitment.
3. Death prior to discharge or recruitment.
4. Patients whose surgery predates enrollment by more than 1 year.
Comparison groups shall be the control groups, individually or together, as appropriate for AVR in the prior IDE trial.
|
| Sample Size |
510
The sample size for the registry was calculated with the following assumptions:
Incidence of composite outcome estimated via
Poisson regression
1-sided test comparing the composite outcome to the reference value
5% significance level
90% power
Expected overall composite proportion from the IDE
high risk treatment group (pT) = 0.0457/patient-year (ptyr)
Reference value (p95, upper 95% confidence bound from PROACT study) =0.0693/ptyr
800 patient-years of follow-up
Anticipated 5 years of follow-up per subject
Loss to follow-up over 5 years of 20%
|
| Key Study Endpoints |
The primary safety endpoint is the composite of major bleeding, total TE and valve thrombosis.
Composite outcome incidence rate in:
Clinic monitored high-risk patients
Clinic monitored low-risk patients
Home monitored low-risk patients
Home monitored high-risk patients
Events are to be considered individually including subsets of bleeding and TE as secondary endpoints.
Death, reoperation and explant when associated with a primary endpoint event shall be reported.
Sudden death will also be recorded as a secondary endpoint.
Asditional Endpoints:
Peripheral TE
Minor bleeding
All bleeding (major and minor)
Ischemic stroke
TIA
Hemorrhagic stroke
Reoperation, explant, and death (associated with valve-related TE, VT, or bleeding)
|
| Follow-up Visits and Length of Follow-up |
5 years
|
