Back to resultsBIO|CONCEPT.BIOMONITOR III
Primary Purpose
Atrial Fibrillation, Syncope, Tachyarrhythmia
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
BIOMONITOR III
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Implantable Cardiac Monitor
Eligibility Criteria
Inclusion Criteria:
- Patient is at high risk of developing a clinically important cardiac arrhythmia; or Patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
- Patient is able to understand the nature of study and has provided written informed consent.
- Patient is willing and able to perform all follow up visits at the study site.
- Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
Exclusion Criteria:
- Patients implanted with ICD or pacemaker.
- Patient is pregnant or breast feeding.
- Patient is less than 18 years old.
- Patient is participating in another interventional clinical investigation
- Patient´s life-expectancy is less than 6 months.
Sites / Locations
- HeartCare Partners - Wesley Testing
- Bundaberg Cardiology
- Princess Alexandra Hospital
- HeartCare Victoria - Doncaster
- Mount Hospital
- The Canberra Hospital
- The Alfred Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BIOMONITOR III
Arm Description
Outcomes
Primary Outcome Measures
Adverse Events
(procedure / device related)
R-wave amplitude
Secondary Outcome Measures
Insertion procedure of the BIOMONITOR III by using the incision and insertion tools
Assessment of insertion procedure by using a questionaire about handling and time record.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03850327
Brief Title
BIO|CONCEPT.BIOMONITOR III
Official Title
BIO|CONCEPT.BIOMONITOR III
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
October 6, 2019 (Actual)
Study Completion Date
October 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
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 objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the BIOMONITOR III will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Syncope, Tachyarrhythmia
Keywords
Implantable Cardiac Monitor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIOMONITOR III
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
BIOMONITOR III
Intervention Description
Patients with ICM indication receive a third-generation implantable cardiac monitor
Primary Outcome Measure Information:
Title
Adverse Events
Description
(procedure / device related)
Time Frame
1 month
Title
R-wave amplitude
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Insertion procedure of the BIOMONITOR III by using the incision and insertion tools
Description
Assessment of insertion procedure by using a questionaire about handling and time record.
Time Frame
At the day of insertion of the BIOMONITOR III
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is at high risk of developing a clinically important cardiac arrhythmia; or Patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
Patient is able to understand the nature of study and has provided written informed consent.
Patient is willing and able to perform all follow up visits at the study site.
Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
Exclusion Criteria:
Patients implanted with ICD or pacemaker.
Patient is pregnant or breast feeding.
Patient is less than 18 years old.
Patient is participating in another interventional clinical investigation
Patient´s life-expectancy is less than 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier van den Brink, Dr.
Organizational Affiliation
The Alfred Hospital, Melbourne, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
HeartCare Partners - Wesley Testing
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Bundaberg Cardiology
City
Bundaberg
State/Province
Queensland
ZIP/Postal Code
4670
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
HeartCare Victoria - Doncaster
City
Balwyn
State/Province
Victoria
ZIP/Postal Code
3103
Country
Australia
Facility Name
Mount Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
The Canberra Hospital
City
Canberra
ZIP/Postal Code
2605
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
BIO|CONCEPT.BIOMONITOR III
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