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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-PEARL 8.0 New Enrollment Study

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Application Number P970029 S014/ PAS001
Current Plan Approved 01/28/2014
Study Name OSB Lead-PEARL 8.0 New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a new enrollment, a prospective single arm study of the

Cardiogenesis PEARL 8.0 Handpiece Delivery System.

Study Population Description Patients treated with PEARL 8.0 Handpiece, Cardiogenesis TMR

must meet the following inclusion criteria:

¿ Class IV angina

¿ 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

¿ amenable to thoracoscopic TMR

AND not meet the exclusino criteria listed below:

¿ 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

The comparison group is the historic control with a non-inferiority margin.

Sample Size Stage 1: 10 patients with no mortalities

Stage 2: 22 patients if 1 mortality in stage 1

Futility: 2 or more mortalities

Site: 5

Sample size calculation assumptions:

Patients will be enrolled at a rate of 1 patient per month,

therefore, 30-day mortality will be known for all currently enrolled patients at the time each new patient is enrolled. The probability of 30-day mortality for the PEARL 8 device, p, has an assumed Beta prior distribution

[p] ~ Beta(0.1, 0.9)

This prior distribution is based on the previous study of the PEARL

8 device and is equivalent to observing one patient¿s worth of information with a mean 30-day mortality rate of 10%.

A minimum of 10 patients will be enrolled. There will be one interim analysis and one final analysis. At each analysis, the number of observed deaths, X, among the currently enrolled patients, N, follows a binomial distribution

[X] ~ Binomial(N, p)

The resulting posterior distribution with the currently observed data (X, N) is

[p | X,N] ~ Beta (0.1X,0.9 +N-X)

The non-inferiority margin for this study is 6.6% (4.4% + 2.2%) and the success criterion at 90%. 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.

Data Collection Primary: 30 day mortality

Secondary: Major adverse coronary and cerebrovascular events


Follow-up Visits and Length of Follow-up 30 days

30 days post procedure

OSB Lead-PEARL 8.0 New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
interim report 10/19/2012 10/19/2012 On Time
one year report 02/21/2013 02/26/2013 Overdue/Received
Interim Report 08/19/2013 08/19/2013 On Time
two year report 02/21/2014 02/21/2014 On Time
three year report 10/01/2016 11/25/2014 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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