CardioGenesis Transmyocardial Revascularization 1-Year Follow-Up Study

NCT02694861 | Completed

• 1 other identifier: TMR1501.001-M (10/15)
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Angina Pectoris; Angina, Stable; Chest Pain

Outcome Measures

Primary Outcomes (1)

• Change in Canadian Cardiovascular Society (CCS) Angina Class from Baseline (Class IV) at 1 Year.

  Class I: Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation; Class II: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions; Class III: Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace; Class IV: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest.

  1 year

Secondary Outcomes (2)

• Rate of all cause mortality

  30 days, 1 year

• Rates of Major Adverse Cardiovascular Events (MACE)

  30 days, 1 year

Study Arms (2)

Registry Group

Patients previously enrolled in the ANGINA RELIEF Registry who are eligible for a 1-year, prospective follow-up (date of ANGINA RELIEF Registry TMR procedure performed within 12-18 month follow-up window).

Prospective Group

A group of up to 100 new, prospectively enrolled patients from active centers that receive TMR with the CardioGenesis Laser System and complete a 30-day and 1-year follow-up.

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

All patients who meet the eligibility criteria at the selected centers will be provided an opportunity to participate.

You may qualify if:

• Registry Group: Previously enrolled in the ANGINA RELIEF Registry; Eligible for a 1-year prospective follow-up (date of TMR procedure performed within 12-18 month follow-up window).
• Prospective Group: Received TMR with the CardioGenesis Laser System; Class IV angina (according to Canadian Cardiovascular Society Angina Scale) prior to TMR; 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).

You may not qualify if:

• Registry Group: Date of ANGINA RELIEF Registry TMR procedure performed outside 1-year (12-18 month) follow-up window.
• Prospective Group: Age less than 18 years; Severely unstable angina (un-weanable from intravenous anti-anginals for 48-hours).

Sponsors & Collaborators

• CryoLife, Inc.: lead

Study Sites (2)

Cardiothoracic and Vascular Surgical Associates

Jacksonville, Florida, 32204, United States

Location

TriStar Cardiovascular Surgery

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Angina Pectoris; Angina, Stable; Chest Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Scott B Capps, MS

  CryoLife, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 1, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: March 4, 2021

Record last verified: 2021-03

Locations

US (2)