Status:
TERMINATED
The PEARL 8.0 Post-Approval Study
Lead Sponsor:
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Conditions:
Class IV Angina
Eligibility:
All Genders
18+ years
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 treat...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01845103
Start Date
September 1 2013
End Date
December 1 2014
Last Update
October 6 2016
Active Locations (1)
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1
Sutter Institute for Medical Research
Sacramento, California, United States, 95816