Tethered AF coagulation system to be evaluated in new clinical trial

Enrollment began in October 2009 with trial completion scheduled for the end of 2011.

A new prospective clinical trial designed to evaluate the safety and efficacy of a tethered atrial fibrillation coagulation system that can be used during concomitant cardiac surgery has been launched by nContact Surgical Inc.

Researchers for the 15-center Numeris-AF Tethered Coagulation with VisiTrax trial began enrolling patients in October 2009, with a planned enrollment of 107 participants with persistent AF set as recruitment goal. The primary efficacy outcome measure is the number of participants free from AF and free of Class I and III antiarrhythmic drugs at nine months following the procedure. Secondary measures include the number of patients free from AF at nine months regardless of antiarrhythmic drug class status. The trial is scheduled for completion in December 2011.

Patients are eligible for inclusion if they are aged 18 to 80 years; have documented longstanding persistent AF or nonself-terminating AF lasting longer than seven days but less than one year; and have had at least one failed direct current cardioversion. Eligible patients must also be scheduled for at least one concomitant cardiac procedure such as CABG; mitral or tricuspid valve repair/replacement; aortic valve replacement; myxoma; or any combination of the procedures.

“The nContact technology enables me to create a comprehensive biatrial lesion pattern on a beating heart,” Edward Garrett, Jr., MD, a cardiologist at Baptist Memorial Hospital Heart Institute in Memphis, Tenn., and an investigator of the study, said in a press release. “We look forward to investigating the ability to treat AF in patients undergoing open heart surgery with the hope of establishing the lesion pattern.”