SyncopeNCT03803969
ConfirmRxTM: Posture and Activity
A study testing ConfirmRx (Insertable Cardiac Monitor) in people with Syncope and Cryptogenic Stroke, run by Abbott Medical Devices at 8 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope, Cryptogenic Stroke
- What is being tested?
- ConfirmRx (Insertable Cardiac Monitor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesAustralia
- Study dates
- 30 Oct 2018to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients will meet all the following:
- Subjects are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
- Subject must provide written informed consent prior to any clinical investigation related procedure.
- Have an approved indication for continuous arrhythmia monitoring with an Insertable Cardiac Monitor.
- Should be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- 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.
Who cannot join
- Patients will be excluded if they meet any of the following:
- Subject has previously received an Insertable Cardiac Monitor.
- 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.
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Australia8 sites
St Andrews Hospital
Adelaide, South Australia, 5000
The Wesley Hospital
Auchenflower, Queensland, 4066
Friendly Society Private Hospital
Bundaberg, Queensland, 4670
Greenslopes Private Hospital
Greenslopes, Queensland, 4120
Warringal Private Hospital
Heidelberg, Victoria, 3084
The Valley Private Hospital
Mulgrave, Victoria, 3170
St John of God Murdoch Hospital
Murdoch, Western Australia, 6150
Mount Hospital
Perth, Western Australia, 6000
About this study
Official title: ConfirmRxTM: Effects of Patient Posture and Physical Activity
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.
Read the detailed description
Syncope is a condition that has vexed cardiologists worldwide due to its elusive nature. Often a third of patients with syncope remain undiagnosed despite assessments by multidisciplinary teams and the availability of various screening techniques such as electrocardiography, 24-h Holter monitoring, carotid sinus massage, echocardiography, exercise testing, head-up tilt test, and electrophysiological studies. Recently, ICM's have been developed to continuously monitor heart rhythm and thus aid in the diagnoses and management of clinical conditions such as ventricular arrhythmias, cryptogenic stroke, recurrent unexplained syncope and for monitoring atrial fibrillations (AF) post ablation. ICM's such as Confirm Rx from Abbott are leadless devices that detect arrhythmias largely depending on sensing of changes in R-R interval and R wave amplitude in the ECG signal. Whilst ICM's have been helpful in detecting arrhythmias in up to 40% of these patients with unexplained syncope, there is paucity of data regarding changes in signal quality with variations in body posture, physical activity and device movements that could potentially have effects on ECG signal and thus event detection. To this extent, this is an Abbott sponsored prospective, single arm, non-randomized, open-label, multi-center, clinical trial of 100 subjects designed to characterize the safety and performance of Confirm Rx™ in relation to physical activity and posture in these subjects with unexplained syncope.
ConfirmRx™ has come a long way since its inception with a significant reduction in size (78% reduction by volume) that has led to relatively simple insertion procedures through a small skin incision. The less complicated insertion process permits the insertion procedure to take place in settings besides operating rooms and furthermore, smaller devices are associated with significantly lower incidence of infections. We believe that this study will add to growing body of evidence of the efficacy of ConfirmRx.
The primary objective of this clinical investigation is to characterise the safety and performance of the Confirm Rx™ Insertable Cardiac Monitor (ICM) by assessing quality of signal attained from device post implant with changes in posture and physical activity at implant and 30days post procedure.
Primary Endpoints
- Changes in R-wave amplitudes at time of insertion and 30 days post-insertion.
- Changes in R-wave amplitude with below defined movements at time of insertion, and 30days post-insertion.
To identify any gross migration of Confirm Rx device 30 days following implant. Secondary Endpoints
- Change in measured distance/position of scar relative to distance from left lateral sternal border at baseline and 30 days
- Measurement of tip of device from left lateral sternal border
- Deviation of proximal tip of device from scar compared to baseline
- Conditions
- Syncope, Cryptogenic Stroke
- Being tested
- ConfirmRx (Insertable Cardiac Monitor)
- Keywords
- Syncope, Cryptogenic Stroke, Physical activity, Posture
- Medical subject headings
- Syncope, Ischemic Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConfirmRx (Insertable Cardiac Monitor)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| ConfirmRx (Insertable Cardiac Monitor) | Other | This is a single arm study where in patients with an approved indication for a cardiac monitor will receive a ConfirmRx Device. Receives: Device: ConfirmRx (Insertable Cardiac Monitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterisation of the safety and performance of Confirm Rx™ with changes in posture and physical activity at implant and 30days post procedure
Patient performs defined movements post insertion of device and assessments are made on the Merlin Programmer. These are repeated 30+15 days post procedure
Measured: 30+15 days post procedure
Secondary outcomes (1)
Identification of any gross migration of Confirm Rx device 30 days following implant
Measurements of location of the device is recorded post procedure and then measured again 30+15 days post procedure
Measured: 30+15 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start30 Oct 2018
- Primary completion30 May 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single arm, unblinded, non-randomized, open-label, multi-center, post-market clinical investigation.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Pavia, MBBS, FRACP, Principal investigator, Fundacion GenesisCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803969
- Sponsor's protocol ID
- ABT-CIP-10250 Ver. A.1
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2019
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36209063
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ConfirmRxTM: Effects of Patient Posture and Physical Activity
- ClinicalTrials.gov ID
- NCT03803969
- Acronym / sponsor ID
- ABT-CIP-10250 Ver. A.1
- Conditions
- Syncope, Cryptogenic Stroke
- Keywords
- Syncope, Cryptogenic Stroke, Physical activity, Posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Syncope is a condition that has vexed cardiologists worldwide due to its elusive nature. Often a third of patients with syncope remain undiagnosed despite assessments by multidisciplinary teams and the availability of various screening techniques such as electrocardiography, 24-h Holter monitoring, carotid sinus massage, echocardiography, exercise testing, head-up tilt test, and electrophysiological studies. Recently, ICM's have been developed to continuously monitor heart rhythm and thus aid in the diagnoses and management of clinical conditions such as ventricular arrhythmias, cryptogenic stroke, recurrent unexplained syncope and for monitoring atrial fibrillations (AF) post ablation. ICM's such as Confirm Rx from Abbott are leadless devices that detect arrhythmias largely depending on sensing of changes in R-R interval and R wave amplitude in the ECG signal. Whilst ICM's have been helpful in detecting arrhythmias in up to 40% of these patients with unexplained syncope, there is paucity of data regarding changes in signal quality with variations in body posture, physical activity and device movements that could potentially have effects on ECG signal and thus event detection. To this extent, this is an Abbott sponsored prospective, single arm, non-randomized, open-label, multi-center, clinical trial of 100 subjects designed to characterize the safety and performance of Confirm Rx™ in relation to physical activity and posture in these subjects with unexplained syncope.
ConfirmRx™ has come a long way since its inception with a significant reduction in size (78% reduction by volume) that has led to relatively simple insertion procedures through a small skin incision. The less complicated insertion process permits the insertion procedure to take place in settings besides operating rooms and furthermore, smaller devices are associated with significantly lower incidence of infections. We believe that this study will add to growing body of evidence of the efficacy of ConfirmRx.
The primary objective of this clinical investigation is to characterise the safety and performance of the Confirm Rx™ Insertable Cardiac Monitor (ICM) by assessing quality of signal attained from device post implant with changes in posture and physical activity at implant and 30days post procedure.
Primary Endpoints
- Changes in R-wave amplitudes at time of insertion and 30 days post-insertion.
- Changes in R-wave amplitude with below defined movements at time of insertion, and 30days post-insertion.
To identify any gross migration of Confirm Rx device 30 days following implant. Secondary Endpoints
- Change in measured distance/position of scar relative to distance from left lateral sternal border at baseline and 30 days
- Measurement of tip of device from left lateral sternal border
- Deviation of proximal tip of device from scar compared to baseline
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single arm, unblinded, non-randomized, open-label, multi-center, post-market clinical investigation.
| Arm | Type | Receives |
|---|---|---|
| ConfirmRx (Insertable Cardiac Monitor) | Other | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
- Subject must provide written informed consent prior to any clinical investigation related procedure.
- Have an approved indication for continuous arrhythmia monitoring with an Insertable Cardiac Monitor.
- Should be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- 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.
Key exclusion criteria (5 listed)
- Subject has previously received an Insertable Cardiac Monitor.
- 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.
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ConfirmRx (Insertable Cardiac Monitor) |
Primary outcome
Characterisation of the safety and performance of Confirm Rx™ with changes in posture and physical activity at implant and 30days post procedure
Time frame: 30+15 days post procedure
Patient performs defined movements post insertion of device and assessments are made on the Merlin Programmer. These are repeated 30+15 days post procedure
1 secondary outcome
Identification of any gross migration of Confirm Rx device 30 days following implant
Time frame: 30+15 days post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Derived from this study: PubMed 36209063Swale 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.
- Individual participant dataSharing planned: No
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Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Pavia, MBBS, FRACP principal investigator
Fundacion GenesisCare
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ConfirmRx (Insertable Cardiac Monitor) in people with Syncope and Cryptogenic Stroke, run by Abbott Medical Devices at 8 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterisation of the safety and performance of Confirm Rx™ with changes in posture and physical activity at implant and 30days post procedure (time frame: 30+15 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03803969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.