BIO|CONCEPT.Amvia Study

Heart Failure Clinical Trial

Official title:

BIO|CONCEPT.Amvia, First in Human Study for the Amvia/Solvia Pacemaker Family

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05610176
• Other study ID #: BA115
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 23, 2022
• Est. completion date: October 2024

Study information

• Verified date: June 2023
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation. The study will be conducted at sites in Australia and New Zealand. It is planned to include 50 subjects in the study. Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. At the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. Programming of the pacemakers will be done according to the participant´s therapeutical needs.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: October 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Standard indication for pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation, including de novo, upgrade or replacement implantations
• 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 for activation of atrial anti-tachycardia pacing (aATP) without known history of atrial arrhythmia, or with permanent atrial fibrillation (AF)
• Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
• Pregnant or breast feeding
• Age less than 18 years
• Participation in another interventional clinical investigation according to the definition given in the study protocol
• Life-expectancy less than 12 months

Related Conditions & MeSH terms

• Bradycardia
• Heart Failure

Intervention

Device:
• Amvia Sky pacemaker or CRT-P device
Subjects with an indication for a pacemaker or CRT-P device will be implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. Device programming will be done according to the medical needs of the subjects.

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik Australia Pty Ltd.	Biotronik SE & Co. KG

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious adverse device effect (SADE)-free rate after 12 months	Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate	12 months