Collect clinical data in order to confirm the clinical safety and performance of the Pamira lead when used in routine clinical practice to support the regulatory post-market strategy in Europe and other regions and validation of promotional claims…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to collect clinical data on the performance and safety
of the Pamira lead by analyzing the Pamira related SADE-d events occurring
during the implantation or in the 6 months thereafter.
Secondary outcome
Secondary objective is to confirm the clinical safety by analyzing the
Pamira-related SADE-d events occurring during the implantation or in the 3 and
12 months thereafter, as well as the assessment of the appropriateness of right
ventricular sensing and pacing at the 6- and 12-month FU.
Background summary
The Pamira lead, has been CE approved in the European Union since January 2023.
This means that the Pamira lead fulfils the European regulatory requirements
for medical device products and therefore can be used in patients with an ICD
indication (also outside clinical investigations). However, the regulatory
approval process also requires the collection of clinical data on the
performance and safety of the lead after market approval (PMCF as requested by
the MDR) when used within routine clinical practice. Thus, this study intends
to collect data which will be used for regulatory purposes (MDR).
Study objective
Collect clinical data in order to confirm the clinical safety and performance
of the Pamira lead when used in routine clinical practice to support the
regulatory post-market strategy in Europe and other regions and validation of
promotional claims by:
• demonstrating clinical safety
• evaluating performance based on sensing and pacing assessment
• collecting additional data of interest to assess other aspects such as the
handling and usability
Study design
Prospective, multi-center, international, open, single-arm study.
Intervention
Collection of safety and performance data during the implantation and FUPs of a
BIOTRONIK ICD with usage of a Pamira lead. A strict FUP schedule needs to be
followed in order to collect the necessary endpoint data from a device
interrogation at the 3-, 6- and 12-month FUP after the implantation + usage of
the BIOTRONIK Home Monitoring system.
Study burden and risks
This study is classified as a PMCF without invasive and/or burdensome
procedures. As the implantation of the Pamira ICD lead does not differ from the
standard implantation procedure of ICD leads, no study specific risks are
associated with the implantation procedure. There are however possible risks
that we do not know about at the moment (residual risks), even in a post market
setting (after successful conformity assessment).
The timing of the study follow-up visits (3-, 6- & 12-month follow up) might
differ from the standard routine in the participating hospitals. The duration
of the follow-up visits is slightly increased compared to the routine
follow-ups due to the data collection for the study on the device features.
The usage of Home Monitoring is mandatory but this is not a burden rather an
advantage for the early detection of events as this is in line with the current
Guidelines (already since 2015 the usage of Home Monitoring is endorsed by the
HRS guidelines: with a Class I (A) recommendation that all patients with an
Cardiac Implantable Electronic Device should be offered Remote Monitoring as
part of the standard FUP management)
Woermannkehre 1
Berlin 12359
DE
Woermannkehre 1
Berlin 12359
DE
Listed location countries
Age
Inclusion criteria
Standard indication for ICD therapy according to clinical guidelines.
Planned for de novo implantation of a BIOTRONIK ICD in combination with a
Pamira ICD lead.
Ability and willingness to use the "CardioMessenger" and acceptance of the
BIOTRONIK Home Monitoring® concept.
See CIP 8.3.1.
Exclusion criteria
Mechanical tricuspid valve prosthesis or a severe tricuspid valve disease.
Cardiac surgical post-implantation procedure planned within 12 months.
See CIP 8.3.2.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05621187 |
| CCMO | NL84823.078.23 |