This study is designed to support the regulatory requirements for obtaining the CE mark for the Solia CSP S lead and to support post-market clinical follow-up requirements for the Amvia family (PMCF). Therefore the primary objective is to show…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint 1 - Amvia related SADE-d free rate through 6 months (in a PMCF
setting)
The safety of Amvia pacemakers will be investigated in a PMCF setting by
determining the SADE-d free rate at 6 months (183 days) after implantation.
SADEs will be considered as primary endpoints if they are possible, probable or
causal related to an investigational device. Purely procedure-related SADEs
(SADE-p) will not be considered.
An internal board will adjudicate SADEs whereby the seriousness and device
relatedness will be re-examined. If any amply documented external physical
influence (e.g. accident, sport, twiddling, pneumothorax) or medical AE caused
the SADE, it does not contribute to this endpoint.
Primary endpoint 2 - Solia CSP S related SADE-d free rate through 6 months (in
a pre-CE label setting)
The safety of the Solia CSP S pacing lead will be investigated (to support the
regulatory requirements to obtain CE mark) by determining the SADE-d free rate
at 6 months (183 days) after implantation. SADEs will be considered as primary
endpoints if they are possible, probable or causal related to an
investigational device. Purely procedure related SADEs (SADE-p) will not be
considered.
An internal board will adjudicate SADEs whereby the seriousness and device
relatedness will be re-examined. If any amply documented external physical
influence (e.g. accident, sport, twiddling, pneumothorax) or medical AE caused
the SADE, it does not contribute to this endpoint.
Secondary outcome
Secondary endpoint 1 - Amvia related SADE-d free rate through 12 months (in a
PMCF setting)
The safety of Amvia pacemakers will be investigated by determining the SADE-d
free rate at 12 months (365 days) after implantation. The same definitions and
adjudication procedures as for the primary endpoints apply.
Secondary endpoint 2 - Solia CSP S related SADE-d free rate through 12 months
(in a Pre-CE label setting)
The safety of the Solia CSP S pacing lead will be investigated by determining
the SADE-d free rate at 12 months (365 days) after implantation. The same
definitions and adjudication procedures as for the primary endpoints apply.
Secondary endpoint 3 - Rate of successful acute CSP implantation of Solia CSP S
All implantations, in which the investigator decides to leave the Solia CSP S
pacing lead permanently in the conduction system, are counted as acute success.
Secondary endpoints 4a and 4b - Appropriateness of sensing (a) and pacing (b)
performance
For the pacing system performance, investigators will be asked whether the
pacing and sensing is adequate at implantation and during follow-up.
Secondary endpoint 5 - Maintenance of physiologic ventricular excitation based
on ECG
At implantation and at the end of each follow-up the investigator is asked to
assess the LBBAP capture response based on the interpretation of a 12-lead ECG
recording according to the ECG-hallmarks of successful stimulation in the LBBA.
Secondary endpoint 6 - Mid-term change in LVEF and LVESV
To monitor possible cardiac remodeling in all patients LVEF and LVESV values
shall be collected at baseline, at the 6-month follow-up, at the 12-month
follow-up and at all following annual in-office follow-ups, if applicable.
Secondary endpoint 7 - Mid-term change in quality of life
To monitor mid-term changes in quality of life, Health-related quality of life
(HRQoL) questionnaires will be filled out by each patient at baseline, at the
6-month follow-up, at the 12- month follow-up and at all following annual
in-office follow-ups, if applicable.
Background summary
Permanent cardiac pacemaker devices, including cardiac resynchronization
therapy pacemaker devices, are essential for treating symptomatic bradycardia
and heart block. Recently, physiological pacing approaches such as left bundle
branch area pacing (LBBAP) have emerged as alternative strategies. These
methods directly pace the conduction system, enabling a more physiological
excitation of the heart. Increasing clinical evidence suggests that conduction
system pacing (CSP) can prevent pacing-induced cardiomyopathy and mitigate the
development or worsening of heart failure.
The 'Amvia' pacemaker family represents BIOTRONIK*s latest generation of
pacemakers that is available on the market for usage with CSP. The pacemakers
and pacing leads investigated in this study are designed to meet the specific
requirements of CSP. The Amvia Sky/Edge pacemakers are already available on the
European market and contain a software tag to indicate the implantation of the
right ventricular lead in the LBB area. The Solia CSP S pacing lead is a
bipolar, 6F, active fixation, steroid-eluting pacing lead with an IS-1
connector that is specifically developed for usage with CSP.
Our research project is submitted as a clinical investigation involving two
investigational devices used in combination for Conduction System Pacing (CSP).
Due to its design and the use of the Solia CSP S lead in a pre-CE label
setting, this clinical investigation falls under Article 62 of the Medical
Device Regulation. This supports the regulatory requirements for obtaining the
CE mark for the Solia CSP S lead. Additionally, BIOTRONIK will use the results
to fulfill Post-Market Clinical Follow-up requirements for the Amvia pacemaker
family.
Study objective
This study is designed to support the regulatory requirements for obtaining the
CE mark for the Solia CSP S lead and to support post-market clinical follow-up
requirements for the Amvia family (PMCF). Therefore the primary objective is to
show clinical safety of the Amvia pacemakers (in a PMCF setting) and the Solia
CSP S leads (in a pre-CE label setting) when used for CSP by analyzing the
related SADE-d events occurring during the implantation or in the 6 months
thereafter.
Secondary objective is to confirm the clinical safety of Amvia pacemakers (in a
PMCF setting) and Solia CSP S leads (in a pre-CE label setting) when used for
CSP by analyzing the related SADE-d events through 12 months after
implantation, as well as the appropriateness of sensing and pacing of the
system during follow-up.
Study design
Open, prospective, international, multi-center, nonrandomized study
Intervention
Pacemaker or CRT-P pacemaker (with CE-mark) with usage of CSP and the Solia CSP
S lead (pre-CE label).
Study burden and risks
Two health-related quality of life questionnaires (SF36 and EQ-5D-5L) will be
taken; at enrollment, 6 month,12 month and during the annual follow up visit.
Woermannkehre 1
Berlin 12359
DE
Woermannkehre 1
Berlin 12359
DE
Listed location countries
Age
Inclusion criteria
For patient enrollment in the study all of the following inclusion criteria
have to be fulfilled at the time of enrollment:
• Standard indication for de novo pacemaker implantation or cardiac
resynchronization therapy
• Patient is intended for implantation of a pacemaker or CRT-P system with left
bundle branch area stimulation
• Ability to understand the nature of the study
• Ability and willingness to perform all follow-up visits at the study site
• Ability and willingness to use the CardioMessenger and acceptance of the
BIOTRONIK Home Monitoring concept
Exclusion criteria
Enrollment of a patient is not permitted if at least one of the following
criteria is fulfilled:
• Planned cardiac surgical procedures or interventional measures other than the
study procedure within the next 12 months
• Expected to receive heart transplantation or ventricular assist device within
12 months
• Life-expectancy less than 12 months
• Pregnant or breast feeding
• Age less than 18 years
• Participation in another interventional clinical investigation (refer to
section 8.3.2 study protocol for details)
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 | NCT06620237 |
| CCMO | NL83481.000.23 |