Coronary Artery DiseasePREVENT-AFNCT03604432
Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery
A study testing propylactic maze in people with Coronary Artery Disease, run by Corewell Health West at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- propylactic maze
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 10 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elective cardiac surgery
- AVR
- CABG
- AVR/CABG
Who cannot join
- History of AF/Aflutter
- Less common cardiac surgeries:
- aortic root replacement
- aortic dissections
- myxoma
- pericardectomies
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
About this study
Official title: Prophylactic Limited Left Sided Maze Procedure to Prevent Post-operative Atrial Fibrillation in Adult Cardiac Surgery Patients
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease
- Being tested
- propylactic maze
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propylactic mazeDevice
Also called Atricure synergy ablation system
Prophylactic limited left sided maze procedure for subjects in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Electric cardiac surgery only |
| Treatment group | Experimental | Elective cardiac surgery plus prophylactic maze procedure Receives: Device: propylactic maze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Documented Post-operative Atrial Fibrillation
Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment.
Measured: 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
the utilization of antiarrhythmic medication required to manage postoperative atrial fibrillation will be recorded
Measured: 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.
record and describe any patient related morbidity or adverse outcome related to the radiofrequency pulmonary vein isolation or left atrial appendage removal
Measured: during the procedure/surgery, up to 8 hours
Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group
the utilization of anticoagulant medications required to manage postoperative atrial fibrillation will be recorded
Measured: immediately after procedure/surgery up to discharge from the hospital, on average 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Feb 2020
- Primary completion13 Dec 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Willekes, Corewell Health West
- Investigators
- Charles L Willekes, MD, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604432
- Sponsor's protocol ID
- 2018-157
- Acronym
- PREVENT-AF
- Status last verified
- Oct 2023
- First submitted
- 19 Jun 2018
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Willekes CL, Fanning JS, Heiser JC, Wai Sang SL, Timek TA, Parker J, Ragagni MK. Randomized feasibility trial of prophylactic radiofrequency ablation to prevent atrial fibrillation after cardiac surgery. J Thorac Cardiovasc Surg. 2024 Jun;167(6):2129-2135.e1. doi: 10.1016/j.jtcvs.2023.03.010. Epub 2023 Mar 17.
PubMed 36933787
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Limited Left Sided Maze Procedure to Prevent Post-operative Atrial Fibrillation in Adult Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT03604432
- Acronym / sponsor ID
- PREVENT-AF / 2018-157
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Electric cardiac surgery only |
| Treatment group | Experimental | Device: propylactic mazeElective cardiac surgery plus prophylactic maze procedure |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Elective cardiac surgery
- AVR
- CABG
- AVR/CABG
Key exclusion criteria (13 listed)
- History of AF/Aflutter
- Less common cardiac surgeries:
- aortic root replacement
- aortic dissections
- myxoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propylactic mazeAlso: Atricure synergy ablation systemProphylactic limited left sided maze procedure for subjects in the treatment arm | Device | Treatment group |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36933787Willekes CL, Fanning JS, Heiser JC, Wai Sang SL, Timek TA, Parker J, Ragagni MK. Randomized feasibility trial of prophylactic radiofrequency ablation to prevent atrial fibrillation after cardiac surgery. J Thorac Cardiovasc Surg. 2024 Jun;167(6):2129-2135.e1. doi: 10.1016/j.jtcvs.2023.03.010. Epub 2023 Mar 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles L Willekes, MD principal investigator
Corewell Health West
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propylactic maze in people with Coronary Artery Disease, run by Corewell Health West at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Documented Post-operative Atrial Fibrillation (time frame: From date of index surgical procedure to date of discharge, on average 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03604432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.