Feasibility of Transepicardial Atrial Injection

Feasibility of Transepicardial Atrial Injection of Saline at the Time Open Chest Cardiac Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiac Surgery
• Intervention / Treatment: Drug: normal saline

Detailed Description

In this project, The investigators will see if patients can undergo successful transepicardial injection of saline at the time of cardiac surgery as compared to no injection. Patients will be randomised in a 1:1 allocation ratio using a parallel two-arm design. The study is designed to meet the following 3 feasibility objectives before proceeding: reasonable recruitment uptake, successful transepicardial injection of saline into the atria, and adequate retention of patients at follow-up.

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Darryl R Davis, MD; Phone Number: 613-696-7298; Email: ddavis@ottawaheart.ca
• Study Contact Backup: Name: Sarah Beaudoin; Phone Number: 613-696-7298; Email: sbeaudoin@ottawheart.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y4W7
      • University of Ottawa Heart Insitute
      • Contact: Darryl Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Undergoing non-emergent open chest cardiac surgery for coronary artery bypass graft (CABG) and/or valve disease.

Exclusion Criteria:

1. Age less than or equal to 18 years of age.
2. Pregnant or breast feeding.
3. Patient is unable or unwilling to provide informed consent.
4. Patient is included in another randomized clinical trial.
5. A history of complex congenital heart disease.
6. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years.
7. 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).
8. Patients for whom the investigator believes that the trial is not in the interest of the patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: saline injection; After the patient is placed on cardiopulmonary bypass, the surgeon will inject a saline into the atria.	Drug: normal saline; Once the patient is placed on cardiopulmonary bypass, the product will be injected into the left atrial wall using a 27 gauge needle as 4 injections of 200 μL each. Two will be placed in the atrial appendage. The remaining 2 injections will be placed equidistant on the anterior atrial free wall. Each injection will be performed just under the surface of the atrial epicardium over 30 seconds. The needle will stay in place for 10 seconds after the injection to limit back flow from the site of injection.; Other Names: 0.9% sodium chloride
No Intervention: standard of care; The patient will be placed on cardiopulmonary bypass as usual and the surgery will proceed without an attempt to inject saline into the atrial tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment uptake	Recruitment uptake <20% (project not feasible), 20-35% (protocol needs to be revised), and > 35% (project feasible).	1 year
Treatment fidelity	Treatment successfully applied < 50% (approach not feasible), 50-75% (approach needs to be revised) and > 75% (approach is feasible).	1 year
Participant retention (follow up)	Follow up: < 65% (project not feasible), 65-85% (follow-up needs to be revised), > 85% (project is feasible).	30 days post surgery

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Darryl Davis, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Pending (Other Identifier: Pending)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No