Collection of Clinical Data on the Safety, Performance and Usability of the Renamic.Neo Programmer System
SYNOPSIS OF THE STUDY
- Main objective: to collect clinical data on the safety, performance and usability of the Renamic Neo Programmer System which consists of the programming device “Renamic Neo”, the programmer software and the new ECG cable.
- The study is also intended to identify and evaluate the residual risks associated with the use of this new Programmer System that remained unrevealed so far
- Duration of the project is 3 months, with preliminary timescale June to September 2020.
- The study is sponsored by BIOTRONIK company that manufactures Renamic Neo programmer
- 120 patients are planned to be recruited worldwide in order to collect the data from 50 implantations and 100 pre-hospital discharge or follow-up cases performed with 20 to 30 Renamic Neo programmer devices.
The participants of the study will be divided into two groups:
Group 1 will include patients that are planned to receive the BIOTRONIK cardiac rhythm management device. The data on those patients will be collected at enrolment, implantation, prehospital discharge and study termination.
Group 2 will include patients with already implanted BIOTRONIK cardiac rhythm management devices; their data will be collected at enrolment, follow-up visit and study termination.
The number of implantations and follow-ups for a specific implant type is also defined for the balanced usage of the specific functions of the Programmer, and it is as follows:
| Type of the implant | Number of implantations | Number of follow-ups |
| Implantable Pulse Generator (IPG) | ~15 | ~20 |
| Implantable Cardioverter Defibrillator (ICD) | ~15 | ~20 |
| Implantable Cardiac Monitor (ICM) | ~20 | |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D)Cardiac Resynchronization Therapy Pacemaker (CRT-P) | ~20 for both types | ~40 for both types |
Inclusion criteria at the time of enrolment:
- Patient is planned for de novo implantation or already has a BIOTRONIK active, implantable device
- Patient is able to understand the nature of the study and provides written informed consent.
Exclusion criteria at the time of enrolment:
- Patient is implanted with a Stratos pacemaker
- Patient is planned for implant exchange or upgrade
- Patient is pregnant or breastfeeding
- Patient is less than 18 years old
