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St Jude Medical reveals Atrial Fibrillation Suppression trial results

St Jude Medical : 06 November, 2007  (New Product)
St Jude Medical has revealed the one-year results from its 409-patient Management of Atrial Fibrillation Suppression in AF-HF Comorbidity Therapy (Mascot) trial.
The Mascot trial was designed to determine whether the St Jude Medical Atrial Fibrillation (AF) Suppression pacing algorithm prevents permanent AF - the most severe stage of AF - in patients receiving cardiac resynchronization therapy (CRT).

This AF Suppression algorithm already has been shown to decrease symptoms of paroxysmal AF (where patients experience episodes of AF) in certain pacemaker patients. Mascot was a European multicentre, prospective randomised trial designed to evaluate the development of AF in CRT patients.

Unexpectedly, the incidence of permanent AF in the control group was much lower (3.3 percent, representing six patients) than anticipated. The incidence of permanent AF was also low, 3.3 percent (seven patients), in the study group.

The low incidence in both groups made it difficult to measure the impact, or to draw conclusions, about AF Suppression therapy's effects in this subgroup of heart failure patients. Based on previous studies, the incidence of permanent AF in the control group was expected to be eight to nine percent.

The study showed the AF Suppression algorithm is safe in these patients and does not impair patient response to CRT, confirming the results observed in a previous St Jude Medical investigational device examination (IDE) clinical study.

'The historic incidence of permanent AF in heart failure patients is around nine percent, but in our trial the surprisingly small percentage of patients with this condition complicated our efforts to assess the benefits of AF Suppression treatment,' said Professor Luigi Padeletti, MD, full professor of cardiology and director of the Postgraduate School of Cardiology, University of Florence, Italy, who was the principal investigator in the study. 'Still, we are encouraged by the positive safety signal observed, and we continue to believe that this approach may represent a major advance in the treatment of AF and heart failure by electrical stimulation.'

The Mascot study was a single-blind, controlled clinical trial that enrolled two groups of patients, all of whom received CRT with a St Jude Medical device. Most patients had severe (NYHA Class III) heart failure, and 19 percent had a history of paroxysmal AF. The active group had the devices programmed with the AF suppression algorithm; that algorithm was turned off in the control group. Patients will be followed for an additional year to evaluate the incidence of permanent AF at two years.

'While in the Mascot trial the incidence of permanent AF in this subgroup of patients was too low to draw conclusions, the previous ADOPT study showed that the AF Suppression feature decreases symptoms of AF in a different subgroup of pacemaker patients, specifically patients with sinus bradycardia (slow heart rates) and paroxysmal (not permanent) AF,' said Mark D Carlson, MD, chief medical officer and senior vice president of clinical affairs in St Jude Medical's Cardiac Rhythm Management Division.

AF and chronic heart failure share many characteristics, with heart failure a common cause of AF and AF often exacerbating heart failure. Both conditions are increasing in prevalence and carry with them significant morbidity, mortality and health care costs.

CRT is a therapy that stimulates both the right and left side of the heart to improve the heart's ability to pump. Current eligibility requirements for implanting a CRT system focus on ejection fraction (the amount of blood the heart pumps with each beat from the ventricle), NYHA Class (severity of heart failure symptoms) and QRS duration (measurement of the heart's electrical dyssynchrony).

Heart failure is a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood to the body. About five million Americans, and six million Europeans, suffer from heart failure. AF is the most common abnormal heart rhythm and affects an estimated 2.3 million people in North America and 4.5 million Europeans.

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