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RethinQ clinical trial results point the way for CRT effectiveness

St Jude Medical : 06 November, 2007  (New Product)
St Jude Medical has announced that the Resynchronization Therapy In Normal QRS (RethinQ) trial, did not reach its primary effectiveness endpoint of improved oxygen consumption at peak exercise (peak VO2).
The RethinQ trial studied a subgroup of heart failure patients, most of whom are currently not indicated for cardiac resynchronization therapy (CRT),

While there was a statistically significant improvement in NYHA class, a secondary endpoint, there was no improvement in quality-of-life, six-minute walk or echocardiographic measures in the patients who received CRT.

The data was presented at the American Heart Association Scientific Sessions 2007 in Orlando, Florida, USA, by Principal Investigator John F Beshai, MD, director, pacemaker and defibrillator services, and assistant professor of medicine at the University of Chicago School of Medicine.

The RethinQ study, which followed 172 patients for six months, was designed to determine whether CRT can help heart failure patients with a narrow QRS complex (the time required for the heart muscle to contract, as measured by electrocardiogram) and left ventricular mechanical dyssynchrony (when the heart's main pumping chambers, the ventricles, do not contract together efficiently).

Patients with a wide QRS already are indicated for CRT therapy. In the RethinQ study, narrow QRS was defined as 130 milliseconds or less (120 milliseconds or less is considered normal).

Notably, the subgroup of patients with QRS duration between 120 and 130 milliseconds showed a statisticall -significant benefit from CRT, as measured by the primary endpoint of exercise duration. This patient subgroup already is indicated for CRT, and this finding supports previous research on this patient subgroup.

Previous studies have suggested, but not proven, that patients with a narrow QRS and with evidence of mechanical dyssynchrony may benefit from CRT. 'While there may be patients with a narrow QRS who can benefit from CRT therapy, the measures of dyssynchrony used in the RethinQ study did not identify them,' said Dr Beshai. 'These new data are helpful for all heart failure physicians as we continue to determine the best criteria for assessing who will most benefit from CRT therapy.'

'Heart failure remains one of the leading causes of death in the USA, underscoring the significant need for more information about potential treatment options,' said Mark D Carlson, M.D, chief medical officer and senior vice president of clinical affairs in St Jude Medical's Cardiac Rhythm Management Division. 'RethinQ will help guide future studies to identify patients who may benefit from ICD and CRT therapy, and adds valuable information to enhance our ability to improve patient outcomes.'

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