The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY Active Fixation and Passive Fixation Pace/ Sense Leads.
Background and Introduction information comes from our attached ICF.
All remaining references are included within attached Company Protocol.
P. 14 (study purpose/objectives)
P. 21-26 (visit details)
P. 27-43 (Statistical methods, data analysis)
Principal Investigator: Roger Freedman