Master Study Investigating the Guiding Catheter Selectra 3D
Launched by BIOTRONIK SE & CO. KG · Mar 25, 2020
Trial Information
Current as of September 06, 2025
Completed
Keywords
ClinConnect Summary
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 ...
Gender
ALL
Eligibility criteria
- 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
About Biotronik Se & Co. Kg
Biotronik SE & Co. KG is a global leader in the development of innovative medical technology, specializing in cardiovascular and endovascular solutions. With a strong commitment to enhancing patient outcomes, the company focuses on advanced therapies and devices, including implantable cardioverter-defibrillators, cardiac resynchronization therapy, and vascular interventions. Biotronik's rigorous research and development initiatives, coupled with its dedication to clinical excellence, position the company at the forefront of medical advancement, striving to improve quality of life for patients worldwide. Through strategic partnerships and a robust clinical trial portfolio, Biotronik continues to drive innovation and set new standards in healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tours, , France
Patients applied
Trial Officials
Uwais Mohamed, PhD
Principal Investigator
The Northern Hospital, Epping, Australia
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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