Ablate AF Trial

For the past eight years, Washington University cardiac surgeons have used the Cox Maze IV procedure to treat atrial fibrillation with about a 90 percent success rate.

Although results at Washington University and several other select centers have been excellent with reported success rates of >90 percent freedom from atrial fibrillation at one year, the results across the country from Cox Maze IV surgery have been varied, says cardiothoracic surgeon Hersh Maniar, MD.

Maniar and his colleagues are involved with a new study, the Ablate AF Trial, to investigate

the reasons behind the variation and to standardize the procedure.

In this open-heart procedure, developed by Ralph Damiano Jr., MD, chief of cardiac surgery, surgeons utilize bipolar radiofrequency energy and cryothermy to create a defined set of ablations and incisions in both atria to restore normal sinus rhythm.

Fifty surgical patients who suffer from atrial fibrillation and are undergoing planned open- heart surgery for other cardiac problems will be offered the Cox Maze IV as a concomitant procedure. These patients will be followed over a two-year period post-surgery to assess their freedom from atrial fibrillation as measured by ECG and Holter monitoring.

Eighteen centers nationwide are participating in this physician-initiated, industry-sponsored study. During each Cox Maze IV surgery, clinical support personnel from AtriCure will be present to record procedural data and ensure that the ablations performed are consistent from institution to institution. AtriCure makes the bipolar radiofrequency device used.

“The key focus in this trial is education and standardization among surgeons. The goal is to determine what type of results can be achieved if you perform a standardized lesion set. We are very excited about seeing these results,” says Maniar. The nationwide Ablate AF trial has already begun enrolling patients.