Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family

Biotronik

Status: Active, not recruiting

Conditions: Bradycardia; Heart Failure

Treatments: Device: Amvia/Solvia pacemaker family

Study type: Interventional

Funder types: Industry

Identifiers

NCT06018818

BA114

Details and patient eligibility

About

The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in the setting of a post-market clinical follow-up study.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

Amvia pacemaker or CRT-P implantation

Other group

Treatment:

Device: Amvia/Solvia pacemaker family