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Completed

NCT Number: NCT03604432

Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

About this study

This is a prospective, single site, randomized, small feasibility study using a FDA approved device for a new indication. Subjects undergoing a CABG, AVR, or CABG/AVR will be randomized 1 to 1 to a control or treatment group. The control group will undergo their index cardiac surgery procedure only. The treatment group will undergo their index cardiac procedure along with a limited left sided maze procedure. The maze procedure will be done with the Atricure synergy ablation system. This is an FDA approved device that will be used for this new indication.

The left sided limited maze procedure will consist of pulmonary vein isolation and removal of the left atrial appendage.

A total of 60 subjects will be enrolled in this study at a single site.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

propylactic maze

Device

Prophylactic limited left sided maze procedure for subjects in the treatment arm

Other names: Atricure synergy ablation system

Primary outcomes

  1. Incidence of Documented Post-operative Atrial Fibrillation

    Time frame: From date of index surgical procedure to date of discharge, on average 1 week.

    Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment.

Secondary outcomes

  1. Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group

    Time frame: immediately after procedure/surgery up to discharge from the hospital, average 1 week

    the utilization of antiarrhythmic medication required to manage postoperative atrial fibrillation will be recorded

  2. Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation.

    Time frame: during the procedure/surgery, up to 8 hours

    record and describe any patient related morbidity or adverse outcome related to the radiofrequency pulmonary vein isolation or left atrial appendage removal

  3. Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group

    Time frame: immediately after procedure/surgery up to discharge from the hospital, on average 1 week

    the utilization of anticoagulant medications required to manage postoperative atrial fibrillation will be recorded

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Registry information

Official study title

Prophylactic Limited Left Sided Maze Procedure to Prevent Post-operative Atrial Fibrillation in Adult Cardiac Surgery Patients

Acronym: PREVENT-AF

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 27, 2018
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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