NCT04323670

Master Study Investigating the Guiding Catheter Selectra 3D

BIO|MASTER.Selectra 3D Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Study investigating the guiding catheter Selectra 3D

Detailed 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.

Conditions

• Pacemaker DDD

Interventions

Type	Name	Description
DEVICE	"Selectra 3D" guiding catheter	His lead measurements

Timeline

• Start date: 2020-10-08
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2020-03-26
• Last updated: 2023-03-03

Locations

1 site across 1 country: France