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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-23

Study Completion Date

2025-07-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Bradycardia Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amvia pacemaker or CRT-P implantation

Group Type OTHER

Amvia/Solvia pacemaker family

Intervention Type DEVICE

Implantation of a pacemaker or CRT-P devices

Interventions

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Amvia/Solvia pacemaker family

Implantation of a pacemaker or CRT-P devices

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No