ID-AF: Comparison of the Performance of Implantable Cardiac Monitors and Cardiac Implantable Electronic Devices in Detecting Atrial Fibrillation

Sponsor
Oxford University Hospitals NHS Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT04940156
Collaborator
(none)
30
1
2
13.9
2.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Confirm Rx (Implantable Cardiac Monitor)
  • Device: Reveal LINQ (Implantable Cardiac Monitor)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparison of the Performance of Implantable Cardiac Monitors and Cardiac Implantable Electronic Devices in Detecting Atrial Fibrillation
Actual Study Start Date :
Oct 4, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Device: Confirm Rx (Implantable Cardiac Monitor)
Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)

Other: LINQ

Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall.

Device: Reveal LINQ (Implantable Cardiac Monitor)
Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)

Outcome Measures

Primary Outcome Measures

  1. To compare the performance of the Confirm Rx™ ICM and Reveal LINQ™ ICM in detecting clinically significant AF episodes (episodes longer than 6 minutes) to CIED (gold standard). [During follow-up (6 months)]

    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 Outcome Measures

  1. To compare the changes in R-wave amplitude following implantation in both ICMs. [During follow-up (6 months)]

    Compare the percentage of changes in R-wave amplitude between both ICMs.

  2. 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.

  3. To compare the number of patient- activated recordings that contains symptoms. attributed to those episodes. [During follow-up (6 months)]

    The percentage of activated recordings with symptoms will be calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 John Radcliffe Hospital Oxford United Kingdom

Sponsors and Collaborators

  • Oxford University Hospitals NHS Trust

Investigators

  • Principal Investigator: Tim Betts, MD MBChB FRCP, Oxford University Hospitals NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tim Betts MD MBChB FRCP, Primary Investigator, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT04940156
Other Study ID Numbers:
  • 14558
First Posted:
Jun 25, 2021
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Tim Betts MD MBChB FRCP, Primary Investigator, Oxford University Hospitals NHS Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2021