Master Study Investigating the Guiding Catheter Selectra 3D

Status Completed

Clinical Trial Summary

Study investigating the guiding catheter Selectra 3D

Clinical Trial Description

The guiding catheter 'Selectra 3D' is a catheter that is intended to support the implantation of a pacemaker lead in untypical positions in the heart like in the His- bundle area. This study is designed as post market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the guiding catheter Selectra 3D that remained unrevealed even after risk analysis, risk mitigation and successful conformity assessment. Moreover, the study aims at providing additional PMCF data, as required by regulatory authorities. Furthermore, the performance and efficacy of the Selectra 3D shall be assessed. The results will be used for updating the clinical evaluation. ;

Study Design

Related Conditions & MeSH terms

Pacemaker DDD

Clinical Trial Details

NCT number	NCT04323670
Study type	Interventional
Source	Biotronik SE & Co. KG
Contact
Status	Completed
Phase	N/A
Start date	October 8, 2020
Completion date	December 22, 2022

View Details

See also
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