Feasibility of Transepicardial Atrial Injection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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saline injection

After the patient is placed on cardiopulmonary bypass, the surgeon will inject a saline into the atria.

Group Type EXPERIMENTAL

normal saline

Intervention Type DRUG

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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0.9% sodium chloride

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No