Atrial FibrillationNCT07100483
Comparing Surgical Management Methods of Atrial Fibrillation
A study testing Atrial Fibrillation Ablation in people with Atrial Fibrillation, run by Corewell Health West at 1 site in United States.
Trial summary
Compare the efficacy of the left atrial Cox-Maze IV lesion set versus the Tampa 2 lesion set versus the EnCompass ablation alone, in the surgical treatment of atrial fibrillation at one year post-operatively. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Atrial Fibrillation Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 15 Sep 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with a history of preoperative atrial fibrillation, either paroxysmal or persistent, requiring concomitant surgical ablation who are scheduled to undergo cardiac surgical procedure(s) to be performed on cardiopulmonary bypass
- Utilizing sternotomy approach requiring cardiopulmonary bypass
- Male or Female subjects between age 18 to 85 years of age
Who cannot join
- LVEF < 25%
- LAVI > 59ml/m②
- Presence of Pacemaker/AICD
- History of VT/VF, WPW
- Re-operative cardiac surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Randomized Trial Comparing Left Atrial Cox-Maze IV, Tampa 2 or Encompass Alone, Ablation in the Surgical Management of Atrial Fibrillation
Compare the efficacy of the left atrial Cox-Maze IV lesion set versus the Tampa 2 lesion set versus the EnCompass ablation alone, in the surgical treatment of atrial fibrillation at one year post-operatively.
Read the detailed description
This is a single center prospective, randomized trial to compare the outcomes, specifically the freedom from atrial fibrillation at one year, and possibly up to five years, of three different approaches to the cardiac surgical management of atrial fibrillation.
Several strategies to accomplish surgical ablation are acceptable and have been shown retrospectively to be successful. The Cox-Maze bi-atrial, left and right atrial lesions, ablation (whether III or IV) remains the gold standard by which all surgical ablations are compared. Further refinement in ablation technology and research has further suggested there is no difference between a left atrial ablation alone or bi-atrial ablation lesion set. For left atrial ablation alone, existent therapeutic options, which all meet equivalent standard of care, include a left atrial Cox-Maze IV , a Tampa 2 lesion set or utilizing a "box lesion" alone. Currently, there are no randomized, clinical trials demonstrating better efficacy (freedom from atrial fibrillation post-operatively) of one ablation strategy over another in patients undergoing cardiac surgery.
The rationale for the study is to demonstrate whether one ablation technique is more efficacious in the surgical treatment of AF. Should one technique prove superior it may clarify the question of which ablation strategy to utilize and encourage surgeons to implement a consistent approach to surgical ablation.
To our knowledge this study would be the first prospective, randomized trial in the United States comparing surgical lesion sets in the concomitant management of atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Atrial Fibrillation Ablation
- Keywords
- AFib, Ablation, Cox IV, Tampa 2, Encompass, Box Lesion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial Fibrillation AblationProcedure or surgery
Ablation of the heart to reduce Afib Occurrence
| Study group | Role | What they receive |
|---|---|---|
| Cox-Maze IV | Active comparator | Lesion created around the pulmonary vein ostia (openings). Lesion to posterior (back) of the mitral annulus (fibrous ring around the mitral valve leaflets). Lesion from the 'box' to the left atrial appendage. There is also one lesion on the outside of the heart at the coronary sinus (main vein draining the heart)- not shown in this picture due to being on the outside of the heart. The Left Atrial Appendage will also be either excluded or removed. Receives: Procedure: Atrial Fibrillation Ablation |
| Tampa 2 | Active comparator | Lesion created around the pulmonary vein ostia (openings). Lesion from the 'box' to the left atrial appendage Lesion from the left atrial appendage to the anterior (front) of the mitral annulus (fibrous ring around the mitral valve leaflets). This lesion is done through the left atrial appendage. The Left Atrial Appendage will also be either excluded or removed. Receives: Procedure: Atrial Fibrillation Ablation |
| Encompass Alone | Active comparator | Lesion created around the pulmonary vein ostia (openings). The Left Atrial Appendage will also be either excluded or removed. Receives: Procedure: Atrial Fibrillation Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Atrial Fibrillation
Freedom from atrial fibrillation at 30 days and one year
Measured: 30 days and 1 year
Secondary outcomes (1)
Prescribed Antiarrhythmic and anticoagulant drugs
Antiarrhythmic and anticoagulant drugs at 7days and one year post surgery
Measured: 7 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start15 Sep 2025
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single enter prospective, randomized trial to compare the outcomes, specifically the freedom from atrial fibrillation at one year, and possibly up to five years, of three different approaches (Cox-Maze IV, Tampa 2, Encompass) to the cardiac surgical management of atrial fibrillation. All patients undergoing an elective, cardiac surgical procedure with documented preoperative AF, either paroxysmal or persistent, with a planned surgical ablation are potential candidates.
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
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 Willekes, MD, Principal investigator, Corewell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100483
- Sponsor's protocol ID
- 2025-1012
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial Comparing Left Atrial Cox-Maze IV, Tampa 2 or Encompass Alone, Ablation in the Surgical Management of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07100483
- Acronym / sponsor ID
- 2025-1012
- Conditions
- Atrial Fibrillation
- Keywords
- AFib, Ablation, Cox IV, Tampa 2, Encompass, Box Lesion
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2032 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the efficacy of the left atrial Cox-Maze IV lesion set versus the Tampa 2 lesion set versus the EnCompass ablation alone, in the surgical treatment of atrial fibrillation at one year post-operatively.
Detailed description
This is a single center prospective, randomized trial to compare the outcomes, specifically the freedom from atrial fibrillation at one year, and possibly up to five years, of three different approaches to the cardiac surgical management of atrial fibrillation.
Several strategies to accomplish surgical ablation are acceptable and have been shown retrospectively to be successful. The Cox-Maze bi-atrial, left and right atrial lesions, ablation (whether III or IV) remains the gold standard by which all surgical ablations are compared. Further refinement in ablation technology and research has further suggested there is no difference between a left atrial ablation alone or bi-atrial ablation lesion set. For left atrial ablation alone, existent therapeutic options, which all meet equivalent standard of care, include a left atrial Cox-Maze IV , a Tampa 2 lesion set or utilizing a "box lesion" alone. Currently, there are no randomized, clinical trials demonstrating better efficacy (freedom from atrial fibrillation post-operatively) of one ablation strategy over another in patients undergoing cardiac surgery.
The rationale for the study is to demonstrate whether one ablation technique is more efficacious in the surgical treatment of AF. Should one technique prove superior it may clarify the question of which ablation strategy to utilize and encourage surgeons to implement a consistent approach to surgical ablation.
To our knowledge this study would be the first prospective, randomized trial in the United States comparing surgical lesion sets in the concomitant management of atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a single enter prospective, randomized trial to compare the outcomes, specifically the freedom from atrial fibrillation at one year, and possibly up to five years, of three different approaches (Cox-Maze IV, Tampa 2, Encompass) to the cardiac surgical management of atrial fibrillation. All patients undergoing an elective, cardiac surgical procedure with documented preoperative AF, either paroxysmal or persistent, with a planned surgical ablation are potential candidates.
| Arm | Type | Receives |
|---|---|---|
| Cox-Maze IV | Active comparator | Procedure: Atrial Fibrillation AblationLesion created around the pulmonary vein ostia (openings). Lesion to posterior (back) of the mitral annulus (fibrous ring around the mitral valve leaflets). Lesion from the 'box' to the left atrial appendage. There is also one lesion on the outside of the heart at the coronary sinus (main vein draining the heart)- not shown in this picture due to being on the outside of the heart. The Left Atrial Appendage will also be either excluded or removed. |
| Tampa 2 | Active comparator | Procedure: Atrial Fibrillation AblationLesion created around the pulmonary vein ostia (openings). Lesion from the 'box' to the left atrial appendage Lesion from the left atrial appendage to the anterior (front) of the mitral annulus (fibrous ring around the mitral valve leaflets). This lesion is done through the left atrial appendage. The Left Atrial Appendage will also be either excluded or removed. |
| Encompass Alone | Active comparator | Procedure: Atrial Fibrillation AblationLesion created around the pulmonary vein ostia (openings). The Left Atrial Appendage will also be either excluded or removed. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with a history of preoperative atrial fibrillation, either paroxysmal or persistent, requiring concomitant surgical ablation who are scheduled to undergo cardiac surgical procedure(s) to be performed on cardiopulmonary bypass
- Utilizing sternotomy approach requiring cardiopulmonary bypass
- Male or Female subjects between age 18 to 85 years of age
Key exclusion criteria (5 listed)
- LVEF < 25%
- LAVI > 59ml/m②
- Presence of Pacemaker/AICD
- History of VT/VF, WPW
- Re-operative cardiac surgery
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 |
|---|---|---|
| Atrial Fibrillation AblationAblation of the heart to reduce Afib Occurrence | Procedure or surgery | Cox-Maze IV, Encompass Alone, Tampa 2 |
Primary outcome
Freedom from Atrial Fibrillation
Time frame: 30 days and 1 year
Freedom from atrial fibrillation at 30 days and one year
1 secondary outcome
Prescribed Antiarrhythmic and anticoagulant drugs
Time frame: 7 days and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Charles Willekes, MD principal investigator
Corewell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial Fibrillation Ablation in people with Atrial Fibrillation, 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 3 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 16 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Freedom from Atrial Fibrillation (time frame: 30 days and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.