5
Participants
Start Date
June 30, 2011
Primary Completion Date
November 30, 2012
Study Completion Date
December 31, 2012
NeuRx RA/4 diaphragmatic pacemaker
"Patients will be implanted with 4 intramuscular electrodes, 2 in each hemi-diaphragm, using laparoscopic techniques.~The abdominal cavity is inflated with CO2 and 4 ports are inserted: one for optics, 2 for a probe containing a temporary electrode for mapping the diaphragm and the electrode insertion tool, and a smaller one for the output wires of the electrodes of the abdominal cavity. The intra-abdominal pressure variation during the stimulation test (mapping) will be measured externally by one of the ports.~Sites that provide the optimal response (greater region and magnitude) are noted.~Once the optimal site for electrode placement is identified two intramuscular electrodes are deployed in each hemi-diaphragm. The guide wires will come out of the peritoneum through the port placed in the xiphoid region. An additional electrode is placed subcutaneously in the upper abdomen. The instruments and ports are then removed and the incision sites closed."
Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo
Collaborators (1)
Synapse Biomedical
INDUSTRY
University of Sao Paulo
OTHER