BIO|CONCEPT.Amvia Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-23

Study Completion Date

2024-06-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06018818

Bradycardia Heart Failure

COMPLETED NA

BIO|MASTER.CSP Study

NCT06620237

Cardiac Pacing, Artificial Cardiac Pacemaker, Artificial Cardiac Resynchronization Therapy Devices +4 more

ACTIVE_NOT_RECRUITING NA

BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family

NCT06840509

Tachycardia Heart Failure

RECRUITING NA

BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S

NCT06540079

Sinus Node Dysfunction Bradycardia Atrioventricular Block

RECRUITING NA

Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF

NCT06384963

Heart Failure With Reduced Ejection Fraction

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bradycardia Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amvia Sky pacemaker or CRT-P implantation

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

Group Type EXPERIMENTAL

Amvia Sky pacemaker or CRT-P device

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No