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Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads — QP ExCELs  

Heart Failure Clinical Trial

Official title:
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads

Clinical Trial Summary

The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in the US. The Sentus OTW QP leads received FDA approval on May 4, 2017. Long-term safety of the BIOTRONIK Sentus OTW QP left ventricular leads will be confirmed during the ongoing post approval phase (US sites only). A protocol update was implemented on September 6, 2019 to transition the long-term follow up for the ongoing Sentus QP Study to a new EP PASSION real-world data methodology.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02290028
Study type Interventional
Source Biotronik SE & Co. KG
Contact
Status Terminated
Phase N/A
Start date December 16, 2014
Completion date January 23, 2020
View Details
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