Surgical Treatments for Atrial Fibrillation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares three surgical methods for treating atrial fibrillation, an irregular heartbeat. Participants will undergo one of three procedures: Cox-Maze IV, Tampa 2, or EnCompass ablation (a type of atrial fibrillation ablation). Each procedure uses specific techniques to create lesions (tissue scarring) around heart structures to help restore normal rhythm. This trial targets individuals with atrial fibrillation requiring surgery who are already scheduled for heart surgery using a sternotomy (chest opening) with a heart-lung machine. As an unphased trial, it offers participants the chance to contribute to valuable research that may enhance surgical options for atrial fibrillation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the surgical ablation procedures—EnCompass, Tampa 2, and Cox-Maze IV—are generally safe.
For the EnCompass procedure, studies have found a few rare cases of minor nerve injury, but these were temporary. Most patients left the hospital without major problems.
The Tampa 2 procedure is designed to be simple and effective. Reports suggest it works as well as or better than the Cox-Maze IV. Recent studies found no issues with the devices used.
The Cox-Maze IV procedure has been tested for many years and is known for keeping the heart rhythm steady. Long-term studies have not found any major safety concerns.
Overall, these procedures are well-tolerated by patients, and studies suggest that any side effects are usually mild.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these surgical treatments for atrial fibrillation because they offer new ways to manage this heart rhythm disorder. Unlike standard treatments like medication, catheter ablation, or electrical cardioversion, these surgical techniques create precise lesions around the heart's structures. The Encompass Alone approach focuses on isolating the pulmonary vein openings, while Tampa 2 and Cox-Maze IV add additional lesion paths to target different areas of the heart, potentially increasing effectiveness. These methods aim to improve the precision and outcomes of atrial fibrillation treatment by directly modifying the heart's electrical pathways, which could lead to better long-term results and fewer complications than current options.
What evidence suggests that this trial's treatments could be effective for atrial fibrillation?
This trial will compare different surgical treatments for atrial fibrillation. Research has shown that the Cox-Maze IV procedure, one of the treatments in this trial, effectively treats atrial fibrillation, especially in patients with a consistent form of this condition. It maintains a high success rate and helps sustain a normal heart rhythm over the long term.
Another treatment option in this trial is the Tampa 2 approach. Early results from previous studies are encouraging, showing that patients who do not respond well to medications have experienced a better quality of life and significant relief from atrial fibrillation.
The EnCompass ablation, also tested in this trial, combines two techniques—pulmonary vein isolation and posterior wall isolation—and studies have shown it greatly improves survival without irregular heartbeats. Each of these treatments appears effective based on previous research.46789Who Is on the Research Team?
Charles Willekes, MD
Principal Investigator
Corewell Health
Are You a Good Fit for This Trial?
This trial is for men and women aged 18 to 85 with a history of atrial fibrillation, who need surgery involving the heart's rhythm pathways. They must be scheduled for a cardiac procedure using cardiopulmonary bypass through a chest incision.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Treatment
Participants undergo one of three surgical ablation techniques: Encompass Alone, Tampa 2, or Cox-Maze IV
Initial Follow-up
Participants are monitored for freedom from atrial fibrillation and prescribed medications post-surgery
Long-term Follow-up
Participants are monitored for freedom from atrial fibrillation and medication use at one year
What Are the Treatments Tested in This Trial?
Interventions
- Atrial Fibrillation Ablation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spectrum Health Hospitals
Lead Sponsor