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CardioGenesis Transmyocardial Revascularization 1-Year Follow-Up Study

NCT02694861 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 114

Last updated 2021-03-04

No results posted yet for this study

Summary

The purpose of this study it to collect real world 30-day and 1-year follow-up data for patients undergoing TMR with the CardioGenesis Holmium:YAG Laser System either as a sole therapy procedure or in conjunction with coronary artery bypass graft (CABG) surgery.

The primary objective of this study is to provide ongoing clinical data regarding the characteristics of the patient population undergoing TMR in community practices. Secondary objectives include rates of postoperative mortality and MACE at 30-days and 1-year, and benefit of sustained improvement in angina at 30-days and 1-year.

The study includes two patient populations:

* Registry Group: Patients from selected centers who previously participated in the ANGINA RELIEF Registry and are eligible for a one-year, prospective follow-up;
* Prospective Group: Up to 100 new, prospectively enrolled TMR patients from selected centers.

Conditions

  • Class IV Angina

Sponsors & Collaborators

  • CryoLife, Inc.

    lead INDUSTRY

Principal Investigators

  • Scott B Capps, MS · CryoLife, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02694861 on ClinicalTrials.gov