NCT01845103

Terminated

The PEARL 8.0 Post-Approval Study

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

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

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

PLT1101.003-M

Study Type

observational

Actual enrollment (reported)

1

Locations

1 country

Sites

1

Timeline

Study Start

September 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2014

Actual (reported)

Study Completion

December 2014

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 1 participants
Study completion date: December 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 30, 2013
Actual (reported)
First Posted
May 3, 2013
Actual (reported)
Study Start
September 2013
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)
Study Completion
December 2014
Actual (reported)
Results Posted
September 30, 2015
Actual (reported)

Last Updated: October 6, 2016
Status Verified: August 2016
Results QC Date: August 28, 2015
Last Update Submitted: August 26, 2016

Conditions

Class IV Angina

Keywords

ANGINAThoracoscopic

Outcome Measures

Primary Outcomes (1)

Mortality
30 day

Secondary Outcomes (1)

Major Adverse Coronary and Cerebrovascular Events (MACCE)
30 day

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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:

Sponsors & Collaborators

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

Study Sites (1)

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

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

Study Officials

Scott B Capps, MS
CryoLife, Inc.
STUDY DIRECTOR

Publication Agreements

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

Enrollment

1 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

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

Contact the study team to confirm eligibility.

Primary Completion

December 2014

Actual (reported)

Study Completion

December 2014

Actual (reported)

Last Updated

October 6, 2016

Results First Posted

September 30, 2015

Record last verified: 2016-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01845103
Data provider: ClinicalTrials.gov
Source updated: 2016-10-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:07 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations