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

Study acronym: COMFORT pilot
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened
    • Start date changed from estimate of Jun 2026 to Aug 31, 2026
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07599553
Lead Sponsor Ottawa Heart Institute Research Corporation
Collaborators: Population Health Research Institute
Conditions
(from sponsor)		 Graft Patency
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov