CHAMPION trial rationale and design: the long-term safety and clinical efficacy of a wireless XXXX pressure monitoring system.

@entity1 @entity712 @entity358
BACKGROUND: Decompensated @entity712 ( @entity712 ) is associated with unacceptable morbidity and mortality risks. Recent implantable technology advancements allow frequent filling pressure monitoring and provide insight into @entity712 pathophysiology and a new tool for @entity712 management. METHODS: The CHAMPION trial is a prospective, multicenter, randomized, single-blind clinical trial testing the hypothesis that @entity712 management guided by frequently assessed @entity358 pressures is superior to traditional methods. A total of 550 subjects with New York Heart Association (NYHA) functional class III @entity712 were enrolled at 64 sites in the United States. All subjects received the CardioMEMS @entity712 sensor as a permanent @entity358 implant and were randomized to the treatment or the control group before discharge. The treatment group received traditional @entity712 management guided by hemodynamic information from the sensor. The control group received traditional @entity712 disease management. Safety endpoints include freedom from device/system-related complications and freedom from @entity712 at 6 months. The efficacy endpoint is a reduction in the rate of @entity712 -related hospitalizations in the treatment group versus the control group at 6 months. CONCLUSIONS: The CHAMPION trial will investigate the safety and clinical efficacy of the CardioMEMS hemodynamic monitoring system and may establish this management strategy as a new paradigm for the medical management of @entity1 with symptomatic @entity712 .
