NCT05610176

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

November 23, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 24, 2025

Completed
Last Updated

July 24, 2025

Status Verified

June 1, 2024

Enrollment Period

1.6 years

First QC Date

November 2, 2022

Results QC Date

April 28, 2025

Last Update Submit

July 23, 2025

Conditions

BradycardiaHeart Failure

Keywords

Cardiac pacemakerCRT-P

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (6)

  • Right Atrial Sensing Amplitude

    12 months

  • Right Atrial Pacing Threshold

    12 months

  • Right Ventricular Sensing Amplitude

    12 months

  • +3 more other outcomes

Study Arms (1)

Amvia Sky pacemaker or CRT-P implantation

EXPERIMENTAL

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

Device: Amvia Sky pacemaker or CRT-P device

Interventions

Amvia Sky pacemaker or CRT-P deviceDEVICE

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.

Amvia Sky pacemaker or CRT-P implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

Location

Advara Heart Care Wesley

Auchenflower, Queensland, 4066, Australia

Location

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7001, Australia

Location

Peninsula Heart Centre

Frankston, Victoria, 3199, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Christchurch Hospital

Christchurch, 8140, New Zealand

Location

MeSH Terms

Conditions

BradycardiaHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Director Clinical Project Management
Organization
BIOTRONIK SE & Co. KG
mathias.freudigmann@biotronik.com
+49 30 68905

Study Officials

  • Justin Mariani, Dr

    The Alfred

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 9, 2022

Study Start

November 23, 2022

Primary Completion

June 11, 2024

Study Completion

June 11, 2024

Last Updated

July 24, 2025

Results First Posted

July 24, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(6)NZ(1)