The PEARL 8.0 Post-Approval Study

NCT01845103 | Terminated Results

• 1 other identifier: PLT1101.003-M
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Class IV Angina

Keywords

ANGINA; Thoracoscopic

Outcome Measures

Primary Outcomes (1)

• Mortality

  30 day

Secondary Outcomes (1)

• Major Adverse Coronary and Cerebrovascular Events (MACCE)

  30 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

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

Study Sites (1)

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Scott Capps, MS/ Vice President, Clinical Research
• Organization: CryoLife, Inc.

clinicaltrialregistration@cryolife.com

800-438-8285

Study Officials

• Scott B Capps, MS

  CryoLife, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 3, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 6, 2016
• Results First Posted: September 30, 2015

Record last verified: 2016-08

Locations

US (1)