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NCT05634213
Feasibility of Transepicardial Atrial Injection
Conditions: Cardiac Surgery, Atrial Disease
Sex: All
Ages: 18 Years – N/A
Phase: EARLY_PHASE1
Enrollment: 78
Sponsor: Ottawa Heart Institute Research Corporation
Summary
Single blind feasibility trial using a binary 'traffic light' design to evaluate the feasibility of injecting normal physiological saline into the atria of patients at the time of clinically indicated open chest cardiac surgery.
Eligibility Criteria
Inclusion Criteria:Undergoing non-emergent open chest cardiac surgery for coronary artery bypass graft (CABG) and/or valve disease.Exclusion Criteria:Age less than or equal to 18 years of age.Pregnant or breast feeding.Patient is unable or unwilling to provide informed consent.Patient is included in another randomized clinical trial.A history of complex congenital heart disease.Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years.Underwent ineligible procedures during or prior to operation (including atrial fibrillation ablation, heart transplantation, pulmonary thromboendarterectomy, isolated thoracic aorta procedures, ventricular assist device insertion, extracorporeal membrane oxygenator insertion, and percutaneous valve replacement).Patients for whom the investigator believes that the trial is not in the interest of the patient.
Source: ClinicalTrials.gov (NCT05634213). StuddyBuddy aggregates publicly available trial information.