N/A N=60 Randomized Prevention

Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery

Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT03604432 ↗

Enrolled (actual)

Serious AEs

45.0%

Results posted

Nov 2023

Primary outcome: Primary: Incidence of Documented Post-operative Atrial Fibrillation — 17; 2 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: propylactic maze (Device)
Age: Older Adult · 70+ yrs
Sex: All
Sponsor: Corewell Health West
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Documented Post-operative Atrial Fibrillation	17; 2	—
SECONDARY Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group	14; 2	—
SECONDARY Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation.	0; 0	—
SECONDARY Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group	7; 1	—

Summary

This study will look at performing a prophylactic limited left sided maze procedure during concomitant adult cardiac surgery to prevent the common occurrence of postoperative atrial fibrillation.

Eligibility Criteria

Inclusion Criteria

Elective cardiac surgery
AVR
CABG
AVR/CABG

Exclusion Criteria

History of AF/Aflutter
Less common cardiac surgeries:
aortic root replacement
aortic dissections
myxoma
pericardectomies
off-pump procedures
redo procedures
Subjects with existing pacemakers, AICD
Vulnerable population
Emergent surgery
Currently participating in investigational drug or device study.
Subjects currently on antiarrhythmic drugs Class I and III including amiodarone.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03604432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.