Feasibility of Transepicardial Atrial Injection

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05634213
• Other study ID #: Pending
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: March 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?brillation 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.

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Insitute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment uptake	Recruitment uptake <20% (project not feasible), 20-35% (protocol needs to be revised), and > 35% (project feasible).	1 year
Primary	Treatment fidelity	Treatment successfully applied < 50% (approach not feasible), 50-75% (approach needs to be revised) and > 75% (approach is feasible).	1 year
Primary	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