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ConfirmRxTM: Posture and 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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2018-10-30
Primary completion: 2024-10-30
Study completion finish: 2024-10-30
Study type
DIAGNOSTIC
Phase
NA
Trial ID
NCT03803969
Intervention or treatment
DEVICE: ConfirmRx (Insertable Cardiac Monitor)
Conditions
- • Syncope
- • Cryptogenic Stroke
Find a site
Closest Location:
The Wesley Hospital
Research sites nearby
Select from list below to view details:
The Wesley Hospital
Auchenflower, Queensland, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Friendly Society Private Hospital
Bundaberg, Queensland, Australia
St Andrews Hospital
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OTHER: ConfirmRx (Insertable Cardiac Monitor)
| DEVICE: ConfirmRx (Insertable Cardiac Monitor)
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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 | 30+15 days post procedure |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| 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 | 30+15 days post procedure |
Frequently Asked Questions
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