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Master Study Investigating the Guiding Catheter Selectra 3D

2020-03-30 04:41:47 | BioPortfolio

Summary

Study investigating the guiding catheter Selectra 3D

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

Conditions

Pacemaker DDD

Intervention

Catheter

Status

Not yet recruiting

Source

Biotronik SE & Co. KG

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-03-30T04:41:47-0400

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