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NCT01827319 · ClinicalTrials.gov registry record

Cardiogenesis Transmyocardial Revascularization Registry

A clinical trial of Class IV Angina, sponsored by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife.

Completed
Registry status
203
Enrollment target
20
Study locations

NCT01827319 is a study of Class IV Angina that has completed, run by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife. The registered enrollment target is 203 participants. The trial reports 20 study locations across 8 states.

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The verdict

NCT01827319, a study of Class IV Angina, has completed, sponsored by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife.

COMPLETED
Registry status
203 participants
Enrollment target
20
Study locations

Study Summary

The objectives of the registry are as follows: * Track "real world" performance outcomes and physician experience using the Cardiogenesis Laser System; * Further define the disease characteristics of the population being treated; * Examine transmyocardial revascularization (TMR) usage characteristics and 30-day outcomes; * Further assess the 30-day postoperative risk factors for adverse events. To limit the potential for bias, all patients eligible for TMR treatment who meet the Inclusion and Exclusion Criteria are to be offered the opportunity to enroll in the study at participating centers.

Conditions Studied

Study Locations (20)

California

  • California Cardiac Surgeons - Bakersfield
  • The Vo Group - Fountain Valley
  • Hurwitz & Roberts Med Corp - Glendale
  • Advanced Cardiothoracic Surgery Medical Group - Los Angeles
  • Soltero & Yasuda Associates Cardiothoracic & Vascular Medical Group - Northridge
  • Cardiovascular & Thoracic Surgeons of Ventura County, APC - Oxnard
  • Joseph W. Wilson, MD, Inc. - Rancho Mirage
  • Sutter Institute for Medical Research - Sacramento

Florida

  • Bethesda Memorial Hospital - Boynton Beach
  • Broward Health Medical Center - Fort Lauderdale
  • Cardiothoracic and Vascular Surgical Associates - Jacksonville
  • Coastal Cardiovascular and Thoracic Associates, PA - Ormond Beach

Kentucky

  • Lexington Cardiac Research Foundation, Inc. - Lexington
  • Owensboro Health, Inc. - Owensboro
  • Regional Heart & Lung Surgery - Paducah

Arizona

  • University of Arizona - Tuscon

Georgia

  • Georgia Health Sciences University Research Institute, Inc. - Augusta

Missouri

  • Saint Luke's Hospital - Kansas City

New Jersey

  • Hackensack University Medical Center - Hackensack

New York

  • The Feinstein Institute for Medical Research - New York

Trial Details

FieldValue
Enrollment Target 203 participants
Start Date 2013-05
Est. Completion 2015-06

What the Registry Record Tells You About NCT01827319

The ClinicalTrials.gov registry entry for NCT01827319 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 203 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Class IV Angina appearing as the primary indexed condition, and to 0 interventions.

NCT01827319 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Kentucky.

Frequently Asked Questions

What is clinical trial NCT01827319 about?

NCT01827319 is a clinical study titled "Cardiogenesis Transmyocardial Revascularization Registry". The objectives of the registry are as follows: * Track "real world" performance outcomes and physician experience using the Cardiogenesis Laser System; * Further define the disease characteristics of the population being treated; * Examine transmyocardial revascularization (TMR) usage characteristi...

What is the current status of trial NCT01827319?

This trial is currently completed. The enrollment target is 203 participants. The study started on 2013-05. Estimated completion is 2015-06.

What conditions does trial NCT01827319 study?

This clinical trial studies the following conditions: Class IV Angina.

Who is sponsoring clinical trial NCT01827319?

This trial is sponsored by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01827319 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.