Class IV Angina Clinical Trial
Official title:
Post-Approval Study of the PEARL 8.0 Handpiece for Transmyocardial Revascularization (TMR) With the Cardiogenesis Holmium:YAG Laser System
This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery System. The purpose of this study is to demonstrate that the 30 day mortality rate among patients who are treated with this device is less than the historical rate plus a non-inferiority margin.
This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery
System. The PEARL 8.0 Handpiece allows the TMR laser energy to be directed at the heart
through a small port up to 8 mm in size. The purpose of this study is to demonstrate that
the 30 day mortality rate among patients who receive this device is less than the historical
rate plus a non-inferiority margin. In a recent study of 34 patients treated with the PEARL
8.0 device, 3 (8.8%) experienced 30 day mortality. Among 132 patients in the original PMA
trial treated with the SoloGrip III Handpiece, a similar device delivering identical energy,
the 30 day mortality rate was 5.3% (7/132). In the Post-Approval Study of the SoloGrip III
Handpiece, 2/72 prospectively enrolled patients died within the first 30 days. Therefore,
the weighted average of the Pre-market and post-market studies has been calculated (4.4%)
and will serve as the historical rate.
This trial will be monitored for success and futility according to a Bayesian adaptive
design. Based on prior history, we assume patients will be accrued at the rate of
approximately 1 patient per month and therefore, 30 day mortality will be known for all
currently enrolled patients at the time each new patient is enrolled.
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.
A secondary objective is to assess the effect of channel number on the 30 day mortality rate
to justify the labeling claims that the risk for early post-operative (30 day) mortality is
associated with an increased number of channels, and not the function of the operation or
device.
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Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01827319 -
Cardiogenesis Transmyocardial Revascularization Registry
|
N/A | |
| Completed |
NCT02694861 -
CardioGenesis Transmyocardial Revascularization 1-Year Follow-Up Study
|