EnSite Real-Time Cardiac Performance Measurements (RT CPM) Study (EnSite RT CPM)
The EnSite Real-Time Cardiac Performance Measurements Study (EnSite RT CPM) is a multicenter, international, acute, non-significant risk study, designed to enroll a maximum of 40 patient. The goal of the study is to collect 3-D systolic/diastolic data with the EnSite NavX Mapping system during a CRT implant.
Patients enrolled in this study will undergo NavX CPM recording of the heart using the EnSite NavX Mapping system during the implantation of a cardiac resynchronization therapy device.
|Study Design:||Time Perspective: Prospective|
|Official Title:||EnSite Real-Time Cardiac Performance Measurements Study, a Non-significant Risk Study|
|Study Start Date:||December 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632450
|United States, California|
|St. Jude Medical|
|Sunnyvale, California, United States, 94086|
|Principal Investigator:||Johannes Sperzel, MD||Kerckhoff Klinik GmbH|
|Principal Investigator:||Andre d'Avila, MD||Massachusetts General Hospital|
|Principal Investigator:||Imran Niazi, MD||Arrhythmia Center of Southern Wisconsin, Ltd|