The PEARL 8.0 Post-Approval Study

Stopped early

Conditions studied: Class IV Angina

In brief

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.

Key facts

Study ID

NCT01845103

Run by

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

People needed

1

Starts

2013-09-01

Expected to finish

2014-12-01

Last updated by the study team

2016-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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