Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device (CLEPSYDRA)
This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT|
- Number of HF related events [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- Co morbidities [ Time Frame: 13 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, physiological Diagnostic (PhD)which as been implemented in the PARADYM CRT Cardiac Resynchronization System with defibrillation capabalities (PARADYM CRT System,model 8770.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02167789
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