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Study of Feasibility for Surgical Patients Undergoing Heart Surgery With the Mammary Arteries: Reviewing Infection, Occlusion Rates and Pain Assessments.

NCT07599553 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-05-20

No results posted yet for this study

Summary

The Pilot study for the COMFORT Trial is a single centre trial to determine the feasibility of the full COMFORT Trial.

The main COMFORT Trial will be a multi-centre trial to investigate the coronary artery bypass grafting outcomes when harvesting the Left Internal Mammary Artery (LIMA) using a skeletonized approach (artery is isolated without the surrounding veins, fascia and nerves) compared to harvesting the LIMA using a non-skeletonized approach (artery is isolated with the surrounding veins, fascia and nerves). Harvesting the LIMA with the non-skeletonized approach is the standard technique. Participants will complete a Coronary Artery Tomography scan at 1 year to determine if the LIMA graft remains open. Follow up of the participants will continue until 2 years post surgery.

Conditions

  • Graft Patency

Interventions

PROCEDURE

Skeletonized vs non-skeletonized harvesting of the left internal mammary artery

This intervention is the surgical technique used to harvest the artery that will be used to perform the bypass surgery.

Sponsors & Collaborators

  • Population Health Research Institute

    collaborator OTHER

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • Fraser Rubens, MD, MSc. · Ottawa Heart Institute Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-09-30
Completion
2028-06-30

Countries

  • Canada

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 NCT07599553 on ClinicalTrials.gov