CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Bicaval cannulation +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04641611
NCT04641611N/ACompleted

Effect of Venous Cannulation Technique on the Incidence of Post-operative Atrial Fibrillation in Patients Undergoing Elective Coronary Artery Bypass Grafting. A Pilot Randomized Controlled Trial.

Dr. Jean-Francois Morin·interventional·Posted Nov 24, 2020·Updated Apr 9, 2024

In Brief

A clinical study evaluating Bicaval cannulation and Cavoatrial cannulation for Atrial Fibrillation. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 24, 2020
Enrollment StartJul 1, 2022
Primary CompletionFeb 1, 2024
Study CompletionMar 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.6 years ago

Interventions

Bicaval cannulationother

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

Cavoatrial cannulationother

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