BIO|MASTER. Amvia: Clinical Follow-up Study after Market Release for the Amvia/Solvia Pacemaker Family
Summary description of the study
The Amvia/Solvia pacemaker family has been CE certified since May 2023 and approved in the EU. The pacemakers meet European regulatory requirements for medical devices and can therefore also be used outside of clinical trials in patients. However, the regulatory approval process also requires the collection of post-marketing data for these devices to assess any potential residual risk. The main objective of this study is to confirm the clinical safety and performance of the new Amvia/Solvia pacemaker family and its new features. The collected data may also be used to support further product development. In this study, the Amvia Sky or Amvia Edge pacemakers are used in combination with the associated new programming software. The pacemakers of the Amvia/Solvia family have additional features compared to older BIOTRONIK pacemakers that better protect against digital threats. They also include new software features. These include atrial antitachycardia pacing (aATP), aimed at terminating atrial tachyarrhythmias, i.e., a rapid rhythm of the upper heart chamber (atrium) and restoring normal heart rhythm, CRT AutoAdapt for continuous adjustment of cardiac resynchronization therapy (CRT), and EarlyCheck as a function for the patient. The study is designed to allow multiple study centers to participate internationally. You and your doctor will be aware of the treatment. There is no experimental and control group in the study, and you will therefore not be assigned to any group by chance. The study is planned to be conducted at up to 15 sites. This will ensure sufficient heterogeneity of sites and investigators to obtain representative results.
(BASEC)
Intervention under investigation
Statistical analysis (Kaplan-Meier estimate) of the rate free from serious adverse events related to the product (SADE-free rate) concerning the Amvia pacemakers after 6 months
(BASEC)
Disease under investigation
This study aims to demonstrate the clinical safety and performance of the new Amvia/Solvia pacemaker family and to substantiate marketing claims. Pacemakers and CRT-P devices are typically used when the heart beats too slowly (bradycardia) or too infrequently, or when the heart muscle is weakened and cannot pump enough blood into the circulation to meet the body's demand for oxygen-rich blood. In the latter case, CRT-P devices aim to optimize the synchronous contraction of the right and left ventricles to improve the heart's pumping function.
(BASEC)
• Standard indication for de novo implantation, upgrade, or replacement of a pacemaker or pacemaker for cardiac resynchronization therapy (CRT-P) • Patient is able to understand the content of the study • Willingness to provide written consent after being informed • Ability and willingness to complete all follow-up examinations at the study center • Ability and willingness to use the CardioMessenger as well as acceptance of the BIOTRONIK Home-Monitoring® concept (BASEC)
Exclusion criteria
• Planned for conduction system pacing • Planned cardiac surgical procedures or interventional measures in addition to the study intervention within the next 12 months • Known pregnancy or breastfeeding • Under 18 years old • Participation in another interventional clinical study • Life expectancy under 12 months (BASEC)
Trial sites
Luzern
(BASEC)
Sponsor
BIOTRONIK SE & Co. KG in Switzerland: BIOTRONIK Schweiz AG
(BASEC)
Contact
Contact Person Switzerland
Laura Nebuloni
+41799197018
laura.nebuloni@clutterbiotronik.comBIOTRONIK Schweiz AG
(BASEC)
General Information
Kliniken Maria Hilf GmbH
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
21.11.2023
(BASEC)
ICTRP Trial ID
NCT06018818 (ICTRP)
Official title (approved by ethics committee)
BIO|MASTER.Amvia Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family (BASEC)
Academic title
BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family (ICTRP)
Public title
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family (ICTRP)
Disease under investigation
Bradycardia
Heart Failure
(ICTRP)
Intervention under investigation
Device: Amvia/Solvia pacemaker family
(ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Standard indication for de novo, upgrade or replacement pacemaker or cardiac
resynchronization therapy pacemaker (CRT-P) implantation
- Ability to understand the nature of the study
- Willingness to provide written informed consent
- 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:
- Planned for conduction system pacing
- Planned cardiac surgical procedures or interventional measures other than the study
procedure within the next 12 months
- Known pregnancy or breast feeding
- Age less than 18 years
- Participation in another interventional clinical investigation
- Life-expectancy less than 12 months
(ICTRP)
not available
Primary and secondary end points
SADE-free rate at 6 months
(ICTRP)
Sensing performance of device-based measurements
Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator
Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator
aATP-related ADEs and SADEs
Auto LV VectorOpt
SADE-free rate at 12 months
CRT AutoAdapt AV delay
CRT AutoAdapt performance
Pacing performance of device-based measurements
(ICTRP)
Registration date
17.07.2023 (ICTRP)
Incorporation of the first participant
23.08.2023 (ICTRP)
Secondary sponsors
not available
Additional contacts
Istvan Szendey, Dr., Kliniken Maria Hilf GmbH (ICTRP)
Secondary trial IDs
BA114 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06018818 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available