Atrial FibrillationID-AFNCT04940156
Comparison of the Performance of ICM and CIED in Detecting AF
A study testing Confirm Rx (Implantable Cardiac Monitor) and Reveal LINQ (Implantable Cardiac Monitor) in people with Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Confirm Rx (Implantable Cardiac Monitor) and Reveal LINQ (Implantable Cardiac Monitor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2021to 23 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
Who cannot join
- Diagnosis of permanent AF.
- Contra-indications for implantable cardiac monitor.
- Unable to comply with the follow-up schedule.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Performance of Implantable Cardiac Monitors and Cardiac Implantable Electronic Devices in Detecting Atrial Fibrillation
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Confirm Rx (Implantable Cardiac Monitor), Reveal LINQ (Implantable Cardiac Monitor)
- Keywords
- Confirm Rx, Reveal LINQ
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confirm Rx (Implantable Cardiac Monitor)Device
Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)
Reveal LINQ (Implantable Cardiac Monitor)Device
Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)
| Study group | Role | What they receive |
|---|---|---|
| Patients implanted with the Abbott Confirm Rx ICM | Other | Patient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall. Receives: Device: Confirm Rx (Implantable Cardiac Monitor) |
| Patients implanted with the Medtronic LINQ ICM | Other | Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall. Receives: Device: Reveal LINQ (Implantable Cardiac Monitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During follow-up (6 months)
Secondary outcomes (3)
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.
Measured: During follow-up (6 months)
To Compare the Transmission Success Rate of Both Devices.
The percentage of successful transmission in both ICMs will be calculated.
Measured: During follow-up (6 months)
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.
Measured: During follow-up (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start4 Oct 2021
- Primary completion23 Nov 2023
- Study completion23 Nov 2023
Why it stopped: Recruitment to study was insufficient. This was despite extending the recruitment period. Decision taken to terminate study due to lack of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust
- Investigators
- Tim Betts, MD FRCP, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940156
- Sponsor's protocol ID
- 14558
- Acronym
- ID-AF
- Status last verified
- Jul 2024
- First submitted
- 17 Jun 2021
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Performance of Implantable Cardiac Monitors and Cardiac Implantable Electronic Devices in Detecting Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04940156
- Acronym / sponsor ID
- ID-AF / 14558
- Conditions
- Atrial Fibrillation
- Keywords
- Confirm Rx, Reveal LINQ
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment to study was insufficient. This was despite extending the recruitment period. Decision taken to terminate study due to lack of recruitment.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients implanted with the Abbott Confirm Rx ICM | Other | Device: Confirm Rx (Implantable Cardiac Monitor)Patient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall. |
| Patients implanted with the Medtronic LINQ ICM | Other | Device: Reveal LINQ (Implantable Cardiac Monitor)Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Diagnosis of permanent AF.
- Contra-indications for implantable cardiac monitor.
- Unable to comply with the follow-up schedule.
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 |
|---|---|---|
| Confirm Rx (Implantable Cardiac Monitor)Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED) | Device | Patients implanted with the Abbott Confirm Rx ICM |
| Reveal LINQ (Implantable Cardiac Monitor)Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED) | Device | Patients implanted with the Medtronic LINQ ICM |
Primary outcome
Assessment of Performance of Confirm Rx ICM and Reveal LINQ ICM in Detecting AF Episodes in Comparison to CIED
Time frame: 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.
3 secondary outcomes
Comparison of Changes in R-wave Amplitude Following Implantation in Both ICMs.
Time frame: During follow-up (6 months)
To Compare the Transmission Success Rate of Both Devices.
Time frame: During follow-up (6 months)
To Compare the Number of Patient-activated Recordings That Contains Symptoms.
Time frame: During follow-up (6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Tim Betts, MD FRCP principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confirm Rx (Implantable Cardiac Monitor) and Reveal LINQ (Implantable Cardiac Monitor) in people with Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assessment of Performance of Confirm Rx ICM and Reveal LINQ ICM in Detecting AF Episodes in Comparison to CIED (time frame: During follow-up (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.