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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03803969




Registration number
NCT03803969
Ethics application status
Date submitted
10/01/2019
Date registered
15/01/2019
Date last updated
9/01/2024

Titles & IDs
Public title
ConfirmRxTM: Posture and Activity
Scientific title
ConfirmRxTM: Effects of Patient Posture and Physical Activity
Secondary ID [1] 0 0
ABT-CIP-10250 Ver. A.1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Syncope 0 0
Cryptogenic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ConfirmRx (Insertable Cardiac Monitor)

Other: ConfirmRx (Insertable Cardiac Monitor) - This is a single arm study where in patients with an approved indication for a cardiac monitor will receive a ConfirmRx Device.


Treatment: Devices: ConfirmRx (Insertable Cardiac Monitor)
This study is designed to characterise the safety and performance of the ConfirmRx device by assessing quality of signal attained from the device with changes in posture and physical activity at implant and 30days post procedure. The study is also intended to assess gross migrations of the device at 30days post implant.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Characterisation of the safety and performance of Confirm Rx™ with changes in posture and physical activity at implant and 30days post procedure
Timepoint [1] 0 0
30+15 days post procedure
Secondary outcome [1] 0 0
Identification of any gross migration of Confirm Rx device 30 days following implant
Timepoint [1] 0 0
30+15 days post procedure

Eligibility
Key inclusion criteria
Eligible patients will meet all the following:

1. Subjects are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
2. Subject must provide written informed consent prior to any clinical investigation related procedure.
3. Have an approved indication for continuous arrhythmia monitoring with an Insertable Cardiac Monitor.
4. Should be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
5. Female subjects of child-bearing potential should have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they meet any of the following:

1. Subject has previously received an Insertable Cardiac Monitor.
2. Subject is currently enrolled or intend to participate in another clinical investigation, which could confound the results of this trial during this clinical study as determined by the sponsor.
3. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
4. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Wesley Hospital - Auchenflower
Recruitment hospital [2] 0 0
Friendly Society Private Hospital - Bundaberg
Recruitment hospital [3] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [4] 0 0
St Andrews Hospital - Adelaide
Recruitment hospital [5] 0 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [6] 0 0
The Valley Private Hospital - Mulgrave
Recruitment hospital [7] 0 0
St John of God Murdoch Hospital - Murdoch
Recruitment hospital [8] 0 0
Mount Hospital - Perth
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4670 - Bundaberg
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3170 - Mulgrave
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment postcode(s) [8] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Insertable Cardiac Monitor's (ICM's) such as Confirm Rx™ are leadless devices implanted for long-term heart rhythm monitoring in the diagnosis and management of clinical conditions such as recurrent unexplained syncope, cryptogenic stroke, ventricular arrhythmias and monitoring atrial fibrillations (AF) post ablation. There is limited data on variations seen in signal sensing with changes in physical activity and posture. This single arm, non-randomized, open-label, multi-center, clinical investigation of 100 subjects is designed to characterise the safety and performance of Confirm RxTM by assessing quality of signal attained from the device with changes in posture and physical activity at implant and 30days post procedure. The study is also intended to assess gross migrations of the device at 30days post implant.
Trial website
https://clinicaltrials.gov/study/NCT03803969
Trial related presentations / publications
Swale M, Paul V, Delacroix S, Young G, McSpadden L, Ryu K, Di Fiore D, Santos M, Tan I, Conradie A, Duong M, Schwarz N, Worthley S, Pavia S. Changes in R-wave amplitude at implantation are associated with gender and orientation of insertable cardiac monitor: observations from the confirm Rx body posture and physical activity study. BMC Cardiovasc Disord. 2022 Oct 8;22(1):439. doi: 10.1186/s12872-022-02752-0.
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Pavia, MBBS, FRACP
Address 0 0
Fundacion GenesisCare
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sinny Delacroix, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
61 8 8202 6651
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03803969