The PEARL 8.0 Post-Approval Study

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.

Study Overview

• Status: Terminated
• Conditions: Class IV Angina

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.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Sutter Institute for Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Coronary and Cerebrovascular Events (MACCE)	MACCE includes: Cardiac related death, CVA, Myocardial Infarction, Serious arrhythmia, CHF	30 day

Collaborators and Investigators

• Sponsor: Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: April 30, 2013
• First Submitted That Met QC Criteria: April 30, 2013
• First Posted (ESTIMATE): May 3, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 6, 2016
• Last Update Submitted That Met QC Criteria: August 26, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Thoracoscopic; ANGINA
• Other Study ID Numbers: PLT1101.003-M