Design and preliminary data of the Metrix Atrioverter expanded indication trial.

The Metrixtrade mark Atrioverter Expanded Indication Trial evaluates the safety and efficacy of an implantable atrial defibrillator in patients with symptomatic, recurrent and drug refractory atrial fibrillation who also have structural heart disease. In this ongoing multicenter study, all patients are anticoagulated and concomitant antiarrhythmic drug treatment is left to the preference of the physician. Holter monitoring is performed prior to enrollment in the study. Spontaneous episodes of atrial fibrillation (AF) are treated under physician observation and when patients are ambulatory, the device is programmed in a monitoring mode. The atrial defibrillation threshold is measured at implantation and at 3, 6 and 12 months thereafter. The performance of the AF detection and R-wave synchronization algorithm is assessed at implantation, at regular follow-up intervals, and each time the patient visits the hospital for treatment of a spontaneous episode of AF. An echocardiogram is performed prior to implantation, at 3 and 6 month follow-up and for patients with an implanted heart valve, after 20 and 50 atrial defibrillation shocks have been delivered. The study started on October 1997 and will end after the last patient enrolled completes his/her six-month post-implantation follow-up, unless a safety issue arises. As of September 1998, 6 patients (2 patients with tachycardia induced cardiomyopathy, 1 patient with a mitral valve prosthesis, 2 patients with hypertrophic cardiomyopathy and 1 patient with congenital heart disease) have been enrolled in the study. Over 350 shocks have been delivered for atrial defibrillation testing or termination of spontaneous AF episodes. There have been no reported cases of ventricular proarrhythmia or inaccurately synchronized shocks and no complications of device therapy in this population.