Insertable Cardiac Monitor for Atrial Fibrillation

(ICMREDUCE-AF Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ilan Goldenberg, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Rochester

Disqualifiers: Permanent AF, NYHA class IV, others

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

To prospectively investigate the efficacy of an insertable cardiac monitor-guided atrial fibrillation (AF) management in reducing subsequent AF burden in patients with persistent or paroxysmal AF undergoing atrial catheter ablation (CA).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Insertable Cardiac Monitor for Atrial Fibrillation?

Research shows that insertable cardiac monitors (ICMs) are effective for long-term monitoring of heart rhythms, including atrial fibrillation (AF), and have a high diagnostic yield, meaning they are good at detecting heart issues. They are also safe and can transmit data quickly to doctors, helping in the management of AF.

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How does the Insertable Cardiac Monitor treatment for atrial fibrillation differ from other treatments?

The Insertable Cardiac Monitor (ICM) is unique because it is a small device implanted under the skin to continuously monitor heart rhythms over a long period, unlike short-term monitors. It can detect atrial fibrillation (irregular heartbeats) more effectively and transmit data to doctors in real-time, allowing for timely treatment adjustments.

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Eligibility Criteria

This trial is for adults with a history of paroxysmal or persistent atrial fibrillation who are undergoing their first catheter ablation. They must have a certain risk score for stroke (CHA2DS2-VASc ≥ 2 in men, ≥ 3 in women), and be able to receive an insertable cardiac monitor. People with severe heart failure, life expectancy less than a year, large left atrium, recent major heart surgery, mechanical valve prosthesis, or those unable to undergo the procedure are excluded.

Inclusion Criteria

I will get an Abbott ICM device for symptom monitoring after cardiac ablation within 2 months of giving consent.

I am 18 years old or older.

CA to be performed for AF within 2 calendar months after consent and prior to randomization date

Exclusion Criteria

Unwillingness to comply with all post-procedural follow-up requirements and to sign informed consent

I cannot tolerate antiarrhythmic drug therapy.

Life expectancy less than 1 year after consent date for any medical condition

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo atrial catheter ablation and are randomized to either conventional AF management or Abbott ICM-guided AF management

3 months (blanking period)

Monitoring

Participants are monitored for AF burden using ICM, CIED, or LT-ECG patch for arrhythmia detection

12 months

Regular follow-up visits for data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study tests if using an insertable cardiac monitor can help manage atrial fibrillation more effectively after catheter ablation. Participants will be monitored to see if this approach reduces the frequency and severity of AF episodes compared to standard care without continuous monitoring.

Group I: ICM/CIED/non-invasive LT-ECG patch arrhythmia detection guided Management Active Control 1 Intervention

Implantable device (ICM/CIED) that provides accurate daily transmission of cardiac electrical data for arrhythmia detection. Patients without an existing CIED who prefer to use noninvasive LT-ECG monitoring will be offered to use the Carnation Ambulatory Monitor ("CAM™"; Bardy Diagnostics). The CAM™ is patch approved for LT-ECG monitoring applied to the skin over the chest for a time-period of 7-days every 2 months for cardiac electrical data for arrhythmia detection.

Group II: Conventional Management Placebo Group 1 Intervention

Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).

Insertable Cardiac Monitor is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Insertable Cardiac Monitor for:

• Atrial fibrillation management
• Syncope diagnosis
• Palpitations diagnosis
• Cryptogenic stroke monitoring

🇪🇺 Approved in European Union as Insertable Cardiac Monitor for:

• Atrial fibrillation management
• Syncope diagnosis
• Palpitations diagnosis
• Cryptogenic stroke monitoring

🇨🇦 Approved in Canada as Insertable Cardiac Monitor for:

• Atrial fibrillation management
• Syncope diagnosis
• Palpitations diagnosis
• Cryptogenic stroke monitoring

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Rochester Medical Center Rochester, NY

Who Is Running the Clinical Trial?

University of Rochester Lead Sponsor

National Heart, Lung, and Blood Institute (NHLBI) Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

New insertable cardiac monitors show high diagnostic yield and good safety profile in real-world clinical practice: results from the international prospective observational SMART Registry. [2023] Insertable cardiac monitors (ICMs) are indicated for long-term monitoring of unexplained syncope or palpitations, and for detection of bradycardia, ventricular tachycardia, and/or atrial fibrillation (AF). The aim of our study was to evaluate the safety and clinical value associated with a new generation ICM (Confirm Rx™, Abbott, Illinois, USA), featuring a new remote monitoring system based on smartphone patient applications.

2. United States pubmed.ncbi.nlm.nih.gov

Real-world performance of an enhanced atrial fibrillation detection algorithm in an insertable cardiac monitor. [2022] Insertable cardiac monitors (ICMs) are used for long-term ECG monitoring. The Reveal LINQ ICM has an improved atrial fibrillation (AF) detection algorithm.

3. England pubmed.ncbi.nlm.nih.gov

Successful modified implantation of insertable cardiac monitor in a very young paediatric patient. [2023] Insertable cardiac monitors are minimally invasive devices designed for implantation in the chest wall of patients to record heart rhythms and relate them to symptoms over prolonged periods. The Jot Dx™ (Abbott Laboratories, Abbott Park, IL, USA) is the latest Food and Drug Administration-cleared insertable cardiac monitor that is Bluetooth™ enabled allowing for near-immediate transmission of data from patients to physicians. We report on the first paediatric patient, in a patient weighing 11.7 kg, to undergo a modified, vertical, parasternal implantation of a Jot Dx™.

4. England pubmed.ncbi.nlm.nih.gov

Implantable loop recorders in patients with atrial fibrillation. [2022] Implantable loop recorders (ILRs) provide practitioners with high-quality electrocardiographic data over an extended monitoring period. These data can guide the diagnosis and management of patients with atrial fibrillation (AF).

5. Malta pubmed.ncbi.nlm.nih.gov

The first case of the Reveal LINQ™ Insertable Cardiac Monitor implanted in a child in Malta. [2022] The Reveal LINQ™Insertable Cardiac Monitor (ICM) or Implantable Loop recorder (ILR), is a miniaturized, subcutaneous, single lead, electrocardiographic monitoring device which has been extensively used in the differential diagnosis of unexplained syncope and palpitations in adults.

6. United States pubmed.ncbi.nlm.nih.gov

Healthcare utilization and clinical outcomes after ablation of atrial fibrillation in patients with and without insertable cardiac monitoring. [2022] Compared with short-term electrocardiogram (ECG) monitors, insertable cardiac monitors (ICMs) have been shown to increase atrial fibrillation (AF) detection rates and the opportunity to treat recurrent AF in patients postablation.

7. United States pubmed.ncbi.nlm.nih.gov

Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two Prospective Trials. [2022] Insertable cardiac monitors (ICMs) are used to continuously monitor the patient's electrocardiogram. In response to patient activation or based on automated device algorithms, arrhythmia episodes are stored and automatically transmitted daily to the clinician. Thus, ICMs can be used to diagnose arrhythmias in at-risk patients and in those with symptoms potentially attributable to arrhythmias. The ICM described in this report has undergone a dramatic change in size and method of insertion.