Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery

NCT03604432 | Completed Results DMC FDA Device

• 1 other identifier: 2018-157
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of Documented Post-operative Atrial Fibrillation

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

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

Secondary Outcomes (3)

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

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

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

  during the procedure/surgery, up to 8 hours

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

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

Study Arms (2)

Control group

NO INTERVENTION

Electric cardiac surgery only

Treatment group

EXPERIMENTAL

Elective cardiac surgery plus prophylactic maze procedure

Device: propylactic maze

Interventions

propylactic maze DEVICE

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

Also known as: Atricure synergy ablation system

Treatment group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Elective cardiac surgery
• AVR
• CABG
• AVR/CABG

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corewell Health West: lead

Study Sites (1)

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Charles Willekes
• Organization: Corewell Health

Charles.Willekes@corewellhealth.org

616-459-7258

Study Officials

• Charles L Willekes, MD

  Corewell Health West

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiothoracic Surgeon

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 27, 2018
• Study Start: February 1, 2020
• Primary Completion: December 13, 2022
• Study Completion: February 10, 2023
• Last Updated: November 7, 2023
• Results First Posted: November 7, 2023

Record last verified: 2023-10

Locations

US (1)