Confirm the safety and efficacy and to access the use and handling of the delivery catheter Selectra 3D
SYNOPSIS OF THE STUDY
- This study is aimed to confirm the safety and efficacy and to access the use and handling of the delivery catheter Selectra 3D which is used to pass the pacemaker lead into the heart via a vein for further connection to a pacemaker.
- The study is sponsored by BIOTRONIK company based in Berlin, Germany via its Australian branch BIOTRONIK Australia Pty Ltd; the company’s pacemaker “Enitra 8” and the pacemaker lead “Solia S” are involved into the research.
- Duration of the study is 24 months with preliminary timescale from April 2020 to January 2022. Recruitment period starts on 1 May 2020 and finishes on 1 May 2021.
- 157 patients are planned to be recruited worldwide
The target population – the patients diagnosed with a necessity to implant a pacemaker.
Participation in the study will consist of:
- Insertion of the pacemaker, followed by BIOTRONIK Home Monitoring
- 3 follow-up visits (3, 6 and 12 months after insertion)
- Self-reporting about any other medical events or medical examinations that occurred during participation in this study
INCLUSION CRITERIA at the time of enrolment:
- Patient is planned for de novo implantation of a pacemaker or cardiac resynchronization implantation
- Patient is intended for guiding catheter-based implantation of a pacemaker system
- Patient is able to understand the nature of the study and provides 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 BIOTRONIC Home Monitoring concept.
EXCLUSION CRITERIA at the time of enrolment:
- AV block with no escape rhythm or broad QRS escape rhythm
- Standard contradictions 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 sever 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 breastfeeding
- Patient is less than 18 years old
- Patient is participating in another interventional clinical investigation according to the definition given below
- Life-expectancy is less than 1 year.
