Effect of Venous Cannulation on the Incidence of Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass

NCT04641611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-09

No results posted yet for this study

Summary

Context Atrial fibrillation is the most frequent arrhythmia following coronary artery bypass grafting. POAF is associated with worse outcomes following CABG. In addition, recurrence of AF is associated with longer hospital stay and higher rate of neurological and renal complications compared to a single episode of AF Objective To estimate the proportion of eligible people who are willing to participate, number of participants who drop out of the trial and use the results of this study to inform a larger study.

Study Design:

Pilot randomized controlled trial. Patients will be blinded to the intervention.

Participants:

The study population will include 40 patients. Patients admitted to the Jewish General Hospital for elective coronary artery bypass grafting from May 2021 will be included in the study. Patients will be included if they were in sinus rhythm with a HR ≥50 bpm, undergoing on-pump coronary artery bypass grafting and hemodynamically stable. Patients will be excluded from the study if they meet any of the following criteria: Second or third degree heart block, LVEF \<35%, left atrial volume index ≥42 ml/m2, right atrial volume index \> 47 ml/m2, any degree of tricuspid regurgitation, any degree of right ventricular dysfunction, emergency or minimally invasive operation, concurrent valve operation, history of atrial fibrillation or previous cardiac surgery

Study Interventions and Measures Patients will be randomly assigned to one of two treatment groups according to the venous cannulation technique used during surgery. Group A will undergo cavoatrial cannulation with a 2-stage venous cannula. Group B will undergo bicaval cannulation with snares. Similar surgical methods will be used in all treatment groups .

The primary endpoint will be defined as any episode of atrial fibrillation in any participant lasting \>5 minutes in duration or any episode leading to hemodynamic compromise (SBP\<90 mmHg) or causing symptoms (angina or dyspnea). Atrial fibrillation will be diagnosed using telemetry and a 12-lead ECG. Patients will be followed up in 1 month with a 12-lead ECG to determine their rhythm. The secondary endpoints are the development of RV dysfunction, tricuspid regurgitation and any increase in left atrial volume index as detected by post-operative transthoracic echocardiography.

Conditions

Interventions

OTHER

Bicaval cannulation

Cannulation of SVC and IVC through right atrium in patients undergoing CABG. with snares applied

OTHER

Cavoatrial cannulation

Cannulating the right atrium and Inferior vena cava with a 2-stage cannula

Sponsors & Collaborators

  • Dr. Jean-Francois Morin

    lead OTHER

Principal Investigators

  • Jean-François Morin, MD,FRCSC · Jewish General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-02-01
Completion
2024-03-01

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04641611 on ClinicalTrials.gov