Surgical Treatments for Atrial Fibrillation

DW
Overseen ByDenise Wittenbach, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Spectrum Health Hospitals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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.46789

Who Is on the Research Team?

CW

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

I have a history of atrial fibrillation and need surgery that involves stopping my heart.
My surgery will involve opening my chest and using a heart-lung machine.
I am between 18 and 85 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Treatment

Participants undergo one of three surgical ablation techniques: Encompass Alone, Tampa 2, or Cox-Maze IV

1 week
1 visit (in-person, surgical procedure)

Initial Follow-up

Participants are monitored for freedom from atrial fibrillation and prescribed medications post-surgery

4 weeks
1 visit (in-person)

Long-term Follow-up

Participants are monitored for freedom from atrial fibrillation and medication use at one year

1 year
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Atrial Fibrillation Ablation
Trial Overview The study compares three surgical techniques for treating atrial fibrillation: the Cox-Maze IV lesion set, Tampa 2 lesion set, and EnCompass ablation alone. The goal is to see which method is most effective one year after surgery.
How Is the Trial Designed?
3Treatment groups
Active Control
Group I: Encompass AloneActive Control1 Intervention
Group II: Tampa 2Active Control1 Intervention
Group III: Cox-Maze IVActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spectrum Health Hospitals

Lead Sponsor

Trials
66
Recruited
553,000+

Citations

Comparing mid‐term outcomes of Cox‐Maze procedure ...Most studies reported that the concomitant Cox‐Maze procedure was associated with higher freedom from AF at 12‐month follow‐up than PVI.
Effectiveness of Maze IV procedure versus thoracoscopic ...In treating paroxysmal AF, CMP-IV and TA demonstrate similar efficacy, but CMP-IV has a higher success rate for non-paroxysmal AF patients.
Late outcomes after the Cox maze IV procedure for atrial ...Recent reports of long-term (>5-year) outcomes after the CMP have demonstrated good results; whereas catheter ablation and pulmonary vein isolation have yielded ...
Safety and efficacy of Cox‐Maze procedure for atrial fibrillation ...Our systematic review suggested that RCTs have demonstrated the addition of the Cox‐Maze procedure for AF leads to a significantly higher rate of sinus rhythm ...
The long-term outcomes and durability of the Cox-Maze IV ...Overall, the CMP-IV had excellent efficacy at maintaining sinus rhythm during the 10 years of follow-up. CMP-IV, Cox-Maze IV procedure; PVI, ...
The long-term outcomes and durability of the Cox-Maze IV ...The CMP-IV had an excellent long-term efficacy at maintaining sinus rhythm. At late follow-up, the results of the CMP-IV remained superior to those reported for ...
The long-term outcomes of concomitant Cox-Maze IV ...The concomitant procedure provided good freedom from atrial tachyarrhythmias of 80% and 65% at years 5 and 10, respectively. The freedom from ...
Long-term Outcomes of Stand-Alone Maze IV for Persistent ...This study confirmed the safety and efficacy in the long term (7 years) of the stand-alone Cox-Maze IV surgical procedure for persistent or long ...
Maze Procedure Success Rates for Atrial FibrillationWhile they generally have high success rates of over 70%, reported success rates can vary for several reasons, including those below.
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