Clinical trial NCT01845103: The PEARL 8.0 Post-Approval Study
Official title: Post-Approval Study of the PEARL 8.0 Handpiece for Transmyocardial Revascularization (TMR) With the Cardiogenesis Holmium:YAG Laser System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Class IV Angina
Keywords: ANGINA
Thoracoscopic
Lead sponsor: Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Class IV angina (according to Canadian Cardiovascular Society Angina Scale)
* 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 (e.g., CABG or PTCA).
* Patients amenable to thoracoscopic TMR.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mortality
timeFrame: 30 day
Secondary outcomes:
measure: Major Adverse Coronary and Cerebrovascular Events (MACCE)
timeFrame: 30 day
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
Study officials:
affiliation: CryoLife, Inc.
name: Scott B Capps, MS
role: STUDY_DIRECTOR
References: