Master Study Investigating the Guiding Catheter Selectra 3D

Study Overview
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Brief Summary
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Study investigating the guiding catheter Selectra 3D

Detailed Description
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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.

Official Title
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BIO|MASTER.Selectra 3D Study

Conditions
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Pacemaker DDD

Intervention / Treatment
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* Device: Selectra 3D guiding catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Standard indication for de novo pacemaker or cardiac resynchronization implantation The patient is intended for guiding catheter based implantation of a pacemaker system Patient is able to understand the nature of the study and has provided written informed consent Patient is willing and able to perform all follow up visits at the study site Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring® concept Exclusion Criteria: AV block with no escape rhythm or broad QRS escape rhythm Standard contraindications for use of the investigational devices: Existing or possible occlusion of the coronary vessels or unsuitable anatomy of the coronary veins Active systemic infection Mechanical tricuspid valve prosthesis or severe tricuspid valve diseases Intolerance against dexamethasone acetate Planned cardiac surgical procedures or interventional measures in addition to the study procedure within the next 6 months Expected to receive heart transplantation or ventricular assist device within 1 year Patient is pregnant or breast feeding Less than 18 years old Participating in another interventional clinical investigation Life-expectancy is less than 1 year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Guiding catheter Selectra 3D
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Selectra 3D<br>Guiding catheter to position the brady lead into a untypical heart position | Device: Selectra 3D guiding catheter<br>* His lead measurements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selectra 3D-related SADE-free rate | Selectra 3D-related Serious adverse device effect rate | 7 days after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful implantation rate | Assessment, if the pacemaker lead is positioned successfully in the intended target position | At the day of implantation | 
| Appropriateness of sensing and pacing of Solia S | Investigator assessment for leads in His position | 12 months | 
| SADE-free rate of Solia S | Safety of Solia S in His position | 6 months | 
| SADE-free rate of Solia S | Safety of Solia S in His position | 12 months |