Back to resultsBIO|CONCEPT.Amvia Study
Primary Purpose
Bradycardia, Heart Failure
Status
Active
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Amvia Sky pacemaker or CRT-P device
Sponsored by
About this trial
This is an interventional treatment trial for Bradycardia focused on measuring Cardiac pacemaker, CRT-P
Eligibility Criteria
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
Sites / Locations
- The Alfred Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Amvia Sky pacemaker or CRT-P implantation
Arm Description
Patients implanted with an Amvia Sky pacemaker or CRT-P device
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05610176
First Posted
November 2, 2022
Last Updated
June 9, 2023
Sponsor
Biotronik Australia Pty Ltd.
Collaborators
Biotronik SE & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT05610176
Brief Title
BIO|CONCEPT.Amvia Study
Official Title
BIO|CONCEPT.Amvia, First in Human Study for the Amvia/Solvia Pacemaker Family
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik Australia Pty Ltd.
Collaborators
Biotronik SE & Co. KG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Heart Failure
Keywords
Cardiac pacemaker, CRT-P
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amvia Sky pacemaker or CRT-P implantation
Arm Type
Experimental
Arm Description
Patients implanted with an Amvia Sky pacemaker or CRT-P device
Intervention Type
Device
Intervention Name(s)
Amvia Sky pacemaker or CRT-P device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serious adverse device effect (SADE)-free rate after 12 months
Description
Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Mariani, Dr
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BIO|CONCEPT.Amvia Study
We'll reach out to this number within 24 hrs