An observational study in Class IV Angina, sponsored by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-06.
Sponsored by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc. · Observational
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.
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
A minimum of two and a maximum of five study sites will be selected for participation. The sites (surgeons) will be selected first from those that participated in the PEARL Study TMR 05-001. If additional sites are required, selection will be made for the sites (surgeons) to be familiar with TMR and thoracoscopic surgery. Sites will be asked to offer all patients eligible for stand-alone thoracoscopic TMR, who meet the inclusion/exclusion criteria, the opportunity to participate in the current study.
Exclusion Criteria:
Mortality
Time frame: 30 day
Major Adverse Coronary and Cerebrovascular Events (MACCE)
MACCE includes: Cardiac related death, CVA, Myocardial Infarction, Serious arrhythmia, CHF
Time frame: 30 day
| Milestone | PEARL 8.0 |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
| percentage of participants | PEARL 8.0 |
|---|---|
| Mortality | 0 |
MACCE includes: Cardiac related death, CVA, Myocardial Infarction, Serious arrhythmia, CHF
| percentage of participants | PEARL 8.0 |
|---|---|
| Major Adverse Coronary and Cerebrovascular Events (MACCE) | 0 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PEARL 8.0 | — | 1/1 (100%) | 0/1 (0%) |
| Event | PEARL 8.0 |
|---|---|
| Serious Adverse Event required hospitalizationRespiratory, thoracic and mediastinal disorders | 1/1 |
| Age, Categorical(Participants) | PEARL 8.0 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 1 |
| Age, Continuous(years) | PEARL 8.0 |
|---|---|
| Mean | 75 |
| Sex: Female, Male(Participants) | PEARL 8.0 |
|---|---|
| Female | 0 |
| Male | 1 |
| Region of Enrollment(participants) | PEARL 8.0 |
|---|---|
| United States | 1 |
This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.