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|
| General |
| Study Status |
Other |
Application Number /
Requirement Number |
P970029 S014/ PAS001 |
| Date Original Protocol Accepted |
02/22/2012
|
| Date Current Protocol Accepted |
01/28/2014
|
| Study Name |
PEARL 8.0 New Enrollment Study
|
| Device Name |
CARDIOGENESIS HOLMIUM TMR SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a new enrollment, a prospective single arm study of the
Cardiogenesis PEARL 8.0 Handpiece Delivery System.
|
| Study Population |
Patients treated with PEARL 8.0 Handpiece, Cardiogenesis TMR
must meet the following inclusion criteria:
¿ Class IV angina
¿ Ejection Fraction > 30%
¿ Patients with regions of myocardium in the distal two- thirds of the left ventricle with reversible ischemia and who are not eligible for direct coronary revascularization
¿ amenable to thoracoscopic TMR
AND not meet the exclusino criteria listed below:
¿ Age less than18-years
¿ Pregnant or nursing mothers
¿ Unable to undergo a surgical procedure or general anesthesia
¿ Hepatic disease, renal failure, cancer or major infection
¿ Severely unstable angina (un-weanable from intravenous anti-anginals for 48-hours)
¿ Patients with mechanical/prosthetic heart valves
¿ Myocardial ischemia limited to the right ventricular wall
¿ Q-Wave myocardial infarction within three (3) weeks prior to the procedure
¿ Non Q-Wave myocardial infarction within two (2) weeks prior to the procedure
¿ Requires anticoagulation medications or has other
hemorrhagic propensity
¿ Severe arrhythmia within one week prior to the procedure
The comparison group is the historic control with a non-inferiority margin.
|
| Sample Size |
Stage 1: 10 patients with no mortalities
Stage 2: 22 patients if 1 mortality in stage 1
Futility: 2 or more mortalities
Site: 5
Sample size calculation assumptions:
Patients will be enrolled at a rate of 1 patient per month,
therefore, 30-day mortality will be known for all currently enrolled patients at the time each new patient is enrolled. The probability of 30-day mortality for the PEARL 8 device, p, has an assumed Beta prior distribution
[p] ~ Beta(0.1, 0.9)
This prior distribution is based on the previous study of the PEARL
8 device and is equivalent to observing one patient¿s worth of information with a mean 30-day mortality rate of 10%.
A minimum of 10 patients will be enrolled. There will be one interim analysis and one final analysis. At each analysis, the number of observed deaths, X, among the currently enrolled patients, N, follows a binomial distribution
[X] ~ Binomial(N, p)
The resulting posterior distribution with the currently observed data (X, N) is
[p | X,N] ~ Beta (0.1X,0.9 +N-X)
The non-inferiority margin for this study is 6.6% (4.4% + 2.2%) and the success criterion at 90%. The success stopping boundaries for this study are 0 10, and 1 22. Thus, if no deaths are observed among the first 10 patients, the study will stop for success. If 1 death is observed among the first 10 patients, the
study will continue to enroll. If among the first 22 patients, only 1 death is observed (there are no additional deaths), the study will stop for success. At any time, if 2 or more deaths are observed, the study will stop for futility.
|
| Key Study Endpoints |
Primary: 30 day mortality
Secondary: Major adverse coronary and cerebrovascular events
(MACCE)
|
| Follow-up Visits and Length of Follow-up |
30 days
30 days post procedure
|
