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NCT04641611Completed

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

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.

Source: ClinicalTrials.gov · Last updated 9 Apr 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
40 (actual)
First submitted
11 Nov 2020
Start date
1 Jul 2022
Primary completion date
1 Feb 2024
Lead sponsor
Dr. Jean-Francois Morin
NCT number
NCT04641611

What you commit to

  • Study type: Interventional
  • Participants enrolled: 40
  • From 1 Jul 2022 to the primary completion date, 1 Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • concurrent valve operation
  • previous cardiac surgery
  • previous catheter ablation for atrial fibrillation

Other illness

  • Second or third degree heart block
  • history of atrial fibrillation

Lab values

  • LVEF \<35%

Other

  • Patients will be excluded from the study if they meet any of the following criteria:
  • 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
  • pre-operative use of class I or III anti-arrhythmics.

Who the study is looking for

  • Patients admitted for coronary artery bypass grafting under the care of the principal investigator at the Jewish General Hospital during the study period will be included if they meet all the following criteria:
  • Age \>18 years
  • Sinus rhythm with HR \>50bpm
  • Scheduled to undergo isolated elective on-pump CABG
  • Hemodynamically stable.

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jewish General Hospital
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.