Study investigating the guiding catheter Selectra 3D
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
157
His lead measurements
CHRU de Tours
Tours, France
Selectra 3D-related SADE-free rate
Selectra 3D-related Serious adverse device effect rate
Time frame: 7 days after implantation
Successful implantation rate
Assessment, if the pacemaker lead is positioned successfully in the intended target position
Time frame: At the day of implantation
Appropriateness of sensing and pacing of Solia S
Investigator assessment for leads in His position
Time frame: 12 months
SADE-free rate of Solia S
Safety of Solia S in His position
Time frame: 6 months
SADE-free rate of Solia S
Safety of Solia S in His position
Time frame: 12 months
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