PMID- 21187258
OWN - NLM
STAT- MEDLINE
DCOM- 20111109
LR  - 20160815
IS  - 1532-8414 (Electronic)
IS  - 1071-9164 (Linking)
VI  - 17
IP  - 1
DP  - 2011 Jan
TI  - CHAMPION trial rationale and design: the long-term safety and clinical efficacy 
      of a wireless pulmonary artery pressure monitoring system.
PG  - 3-10
LID - 10.1016/j.cardfail.2010.08.002 [doi]
AB  - BACKGROUND: Decompensated heart failure (HF) is associated with unacceptable 
      morbidity and mortality risks. Recent implantable technology advancements allow 
      frequent filling pressure monitoring and provide insight into HF pathophysiology 
      and a new tool for HF management. METHODS: The CHAMPION trial is a prospective, 
      multicenter, randomized, single-blind clinical trial testing the hypothesis that 
      HF management guided by frequently assessed pulmonary artery pressures is 
      superior to traditional methods. A total of 550 subjects with New York Heart 
      Association (NYHA) functional class III HF were enrolled at 64 sites in the 
      United States. All subjects received the CardioMEMS HF sensor as a permanent 
      pulmonary artery implant and were randomized to the treatment or the control 
      group before discharge. The treatment group received traditional HF management 
      guided by hemodynamic information from the sensor. The control group received 
      traditional HF disease management. Safety endpoints include freedom from 
      device/system-related complications and freedom from HF sensor failure at 6 
      months. The efficacy endpoint is a reduction in the rate of HF-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 patients with 
      symptomatic HF.
CI  - Copyright (c) 2011 Elsevier Inc. All rights reserved.
FAU - Adamson, Philip B
AU  - Adamson PB
AD  - Heart Failure Institute at Oklahoma Heart Hospital and the Oklahoma Foundation 
      for Cardiovascular Research, Oklahoma City, Oklahoma 73120, USA. 
      padamson@ocaheart.com
FAU - Abraham, William T
AU  - Abraham WT
FAU - Aaron, Mark
AU  - Aaron M
FAU - Aranda, Juan M Jr
AU  - Aranda JM Jr
FAU - Bourge, Robert C
AU  - Bourge RC
FAU - Smith, Andrew
AU  - Smith A
FAU - Stevenson, Lynne W
AU  - Stevenson LW
FAU - Bauman, Jordan G
AU  - Bauman JG
FAU - Yadav, Jay S
AU  - Yadav JS
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Card Fail
JT  - Journal of cardiac failure
JID - 9442138
SB  - IM
CIN - Lancet. 2016 Aug 6;388(10044):564. PMID: 27511785
MH  - Blood Pressure Determination/adverse effects/instrumentation/methods
MH  - Blood Pressure Monitoring, Ambulatory/*adverse effects/*instrumentation/methods
MH  - Heart Failure/diagnosis/*physiopathology
MH  - Humans
MH  - Prospective Studies
MH  - Safety
MH  - Single-Blind Method
MH  - Time Factors
MH  - Treatment Outcome
MH  - Wireless Technology/*instrumentation
EDAT- 2010/12/29 06:00
MHDA- 2011/11/10 06:00
CRDT- 2010/12/29 06:00
PHST- 2010/04/30 00:00 [received]
PHST- 2010/07/28 00:00 [revised]
PHST- 2010/08/09 00:00 [accepted]
PHST- 2010/12/29 06:00 [entrez]
PHST- 2010/12/29 06:00 [pubmed]
PHST- 2011/11/10 06:00 [medline]
AID - S1071-9164(10)01049-3 [pii]
AID - 10.1016/j.cardfail.2010.08.002 [doi]
PST - ppublish
SO  - J Card Fail. 2011 Jan;17(1):3-10. doi: 10.1016/j.cardfail.2010.08.002.