BIO|MASTER. Amvia: Clinical Follow-up Study after Market Release for the Amvia/Solvia Pacemaker Family
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
• 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)
Luogo dello studio
Luzern
(BASEC)
Sponsor
BIOTRONIK SE & Co. KG in Switzerland: BIOTRONIK Schweiz AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Laura Nebuloni
+41799197018
laura.nebuloni@clutterbiotronik.comBIOTRONIK Schweiz AG
(BASEC)
Informazioni generali
Kliniken Maria Hilf GmbH
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
21.11.2023
(BASEC)
ID di studio ICTRP
NCT06018818 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
BIO|MASTER.Amvia Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family (BASEC)
Titolo accademico
BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family (ICTRP)
Titolo pubblico
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family (ICTRP)
Malattie studiate
Bradycardia
Heart Failure
(ICTRP)
Intervento studiato
Device: Amvia/Solvia pacemaker family
(ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
17.07.2023 (ICTRP)
Inclusione del primo partecipante
23.08.2023 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
Istvan Szendey, Dr., Kliniken Maria Hilf GmbH (ICTRP)
ID secondari
BA114 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06018818 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile