Comparison of the Performance of ICM and CIED in Detecting AF (ID-AF)

July 22, 2024 updated by: Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Patients implanted with the Abbott Confirm Rx ICM
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: Patients implanted with the Medtronic LINQ ICM
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
During follow-up (6 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of Changes in R-wave Amplitude Following Implantation in Both ICMs.
Time Frame: During follow-up (6 months)
A comparison will be made between the percentage of change in R-wave amplitudes between both ICMs.
During follow-up (6 months)
To Compare the Transmission Success Rate of Both Devices.
Time Frame: During follow-up (6 months)
The percentage of successful transmission in both ICMs will be calculated.
During follow-up (6 months)
To Compare the Number of Patient-activated Recordings That Contains Symptoms.
Time Frame: During follow-up (6 months)
The percentage of patient-activated recordings with symptoms attributed to those episodes will be calculated.
During follow-up (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oxford University Hospitals NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tim Betts, MD FRCP, Oxford University Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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