Status:
COMPLETED
Master Study Investigating the Guiding Catheter Selectra 3D
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Pacemaker DDD
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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 desig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT04323670
Start Date
October 8 2020
End Date
December 22 2022
Last Update
March 3 2023
Active Locations (1)
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1
CHRU de Tours
Tours, France