BIO|CONCEPT.Amvia Study

Biotronik

Status: Completed

Conditions: Bradycardia; Heart Failure

Treatments: Device: Amvia Sky pacemaker or CRT-P device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05610176

BA115

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Amvia Sky pacemaker or CRT-P implantation

Experimental group

Description:

Patients implanted with an Amvia Sky pacemaker or CRT-P device

Treatment:

Device: Amvia Sky pacemaker or CRT-P device