Feasibility of Transepicardial Atrial Injection

NCT05634213 | Withdrawn Early Phase 1 DMC

• 1 other identifier: Pending
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

saline injection

EXPERIMENTAL

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

Drug: normal saline

standard of care

NO INTERVENTION

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.

Interventions

normal saline 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.

Also known as: 0.9% sodium chloride

saline injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Insitute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Interventions

Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Darryl Davis

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 2, 2022
• Study Start: March 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)