50
Participants
Start Date
October 31, 2007
Primary Completion Date
September 30, 2010
Study Completion Date
December 31, 2013
Phrenic stimulation device
In Stage 1, a stimulation lead will be introduced via standard access methods and positioned to provide stimulation. A second lead may also be placed for sensing purposes. The proximal portions of the implanted lead(s) will remain externalized such that stimulation and observation can be made using external stimulation and recording equipment. Study subjects will be observed and stimulation will be performed for up to 2 nights of sleep in a clinically supported environment. In Stage 2, a stimulation device and lead will be permanently implanted.
Hennepin County Medical Center, Minneapolis
Ohio Heart Hospital, Cincinnati
The Ohio State University, Columbus
Jiangsu Province Hospital, Nanjing
Polish Military Hospital, Wroclaw
Respicardia, Inc.
INDUSTRY