Atrial Fibrillation
Conditions
Keywords
Confirm Rx, Reveal LINQ
Brief summary
The aim of this project is to study the performance of the two most commonly used Implantable Cardiac Monitors in detecting AF episodes and explore how the new connectivity can empower patients and improve patient care.
Detailed description
Atrial fibrillation (AF) is the most common abnormal heart rhythm disturbance, affecting 1-2 million people in the UK. The irregular heartbeat caused by AF can make the heart pump blood less efficiently. As a result, AF significantly increases the risk of having a stroke, heart failure and dementia. However, a significantly proportion of people have no symptoms, and they may be only found to be in AF after having a stroke. Therefore, diagnosis largely relies on accurate electrocardiogram (ECG) monitoring. AF episodes can be unpredictable and easily missed unless continuous ECG monitoring is undertaken. Pacemakers can continuously record the heart's electrical activity and detect AF with a high degree of confidence. However, they are invasive and rely on electrical wires implanted inside the heart, and hence less suited to be used as primary monitoring devices. To overcome these difficulties, implantable cardiac monitors (ICM) have been designed to be placed under the skin. The new generation of ICMs can now be injected under the skin. Moreover, they connect with the patient's smartphone and transmit recordings. Despite these significant improvements, their ability to reliably capture AF has never been tested against pacemakers. The aim of this project is to study the performance of the two commonly used ICMs in detecting AF episodes and explore how the new connectivity can empower patients and improve patient care. The investigators plan to inject an ICM in 30 patients with AF and pre-existing pacemaker. After a period of 6 months, the investigators will compare how many episodes were detected in each device. With the information collected the investigators will try to understand the pitfalls in the current technology and develop strategies to improve it. Accurate, minimally invasive long-term ECG monitor can have far reaching benefits for patients, both in routine clinical practice and research.
Interventions
DEVICEConfirm Rx (Implantable Cardiac Monitor)
Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)
DEVICEReveal LINQ (Implantable Cardiac Monitor)
Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)
Sponsors
Oxford University Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is willing and able to give informed consent for participation in the trial. * Male or Female. * Aged 18 years or above. * History of paroxysmal and persistent AF. * Dual-chamber pacemaker, Implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy (CRT) device with a functioning atrial lead, able to record electrograms and remote monitoring.
Exclusion criteria
* Diagnosis of permanent AF. * Contra-indications for implantable cardiac monitor. * Unable to comply with the follow-up schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Performance of Confirm Rx ICM and Reveal LINQ ICM in Detecting AF Episodes in Comparison to CIED | During follow-up (6 months) | To assess the performance of the Confirm Rx™ ICM and Reveal LINQ™ ICM in detecting clinically significant AF episodes (episodes longer than 6 minutes) in comparison to CIED (gold standard). Confirm Rx and Reveal LINQ™ ICM sensitivity, specificity, positive predictive value and negative predictive value will be calculated for AF episodes longer than 6 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Changes in R-wave Amplitude Following Implantation in Both ICMs. | During follow-up (6 months) | A comparison will be made between the percentage of change in R-wave amplitudes between both ICMs. |
| To Compare the Transmission Success Rate of Both Devices. | During follow-up (6 months) | The percentage of successful transmission in both ICMs will be calculated. |
| To Compare the Number of Patient-activated Recordings That Contains Symptoms. | During follow-up (6 months) | The percentage of patient-activated recordings with symptoms attributed to those episodes will be calculated. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Confirm Rx Patient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall.
Confirm Rx (Implantable Cardiac Monitor): Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED) | 5 |
| LINQ Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall.
Reveal LINQ (Implantable Cardiac Monitor): Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED) | 1 |
| Total | 6 |
Baseline characteristics
| Characteristic | Confirm Rx | LINQ | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 1 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Count of participants | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 1 Participants | 6 Participants |
| Region of Enrollment United Kingdom | 5 participants | 1 participants | 6 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 1 |
| other Total, other adverse events | 0 / 5 | 0 / 1 |
| serious Total, serious adverse events | 0 / 5 | 0 / 1 |
Outcome results
Primary
Assessment of Performance of Confirm Rx ICM and Reveal LINQ ICM in Detecting AF Episodes in Comparison to CIED
To assess the performance of the Confirm Rx™ ICM and Reveal LINQ™ ICM in detecting clinically significant AF episodes (episodes longer than 6 minutes) in comparison to CIED (gold standard). Confirm Rx and Reveal LINQ™ ICM sensitivity, specificity, positive predictive value and negative predictive value will be calculated for AF episodes longer than 6 minutes.
Time frame: During follow-up (6 months)
Population: Data were not collected.
Secondary
Comparison of Changes in R-wave Amplitude Following Implantation in Both ICMs.
A comparison will be made between the percentage of change in R-wave amplitudes between both ICMs.
Time frame: During follow-up (6 months)
Population: Data were not collected.
Secondary
To Compare the Number of Patient-activated Recordings That Contains Symptoms.
The percentage of patient-activated recordings with symptoms attributed to those episodes will be calculated.
Time frame: During follow-up (6 months)
Population: Data were not collected.
Secondary
To Compare the Transmission Success Rate of Both Devices.
The percentage of successful transmission in both ICMs will be calculated.
Time frame: During follow-up (6 months)
Population: Data were not collected.