Master Study Investigating the Guiding Catheter Selectra 3D
NCT ID: NCT04323670
Last Updated: 2023-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
157 participants
INTERVENTIONAL
2020-10-08
2022-12-22
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Selectra 3D
Guiding catheter to position the brady lead into a untypical heart position
"Selectra 3D" guiding catheter
His lead measurements
Interventions
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"Selectra 3D" guiding catheter
His lead measurements
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Uwais Mohamed, PhD
Role: PRINCIPAL_INVESTIGATOR
The Northern Hospital, Epping, Australia
Locations
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CHRU de Tours
Tours, , France
Countries
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Other Identifiers
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BA110
Identifier Type: -
Identifier Source: org_study_id
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