Insertable Cardiac Monitor for Atrial Fibrillation

(ICMREDUCE-AF Trial)

Overseen By Kathy Honsinger, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Permanent AF, NYHA class IV, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months (blanking period)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an insertable cardiac monitor (a small device implanted under the skin to track heart rhythm) can improve atrial fibrillation (AF) management for individuals undergoing atrial catheter ablation (CA). The trial will compare two groups: one using the monitor to track heart rhythm and another following conventional management without monitor data. It suits those who have experienced AF episodes that either resolve on their own or last under three years and are planning to undergo CA soon. Participants should not have permanent AF lasting over three years or severe heart failure. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance AF management.

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 prior data suggests that this insertable cardiac monitor is safe for atrial fibrillation management?

Research has shown that insertable cardiac monitors (ICMs) are very safe. Studies indicate that patients generally tolerate these devices well, with few reports of serious side effects. Many patients have shared positive experiences with ICMs. These monitors accurately detect irregular heartbeats and send important information to doctors.

Overall, ICMs have an excellent safety record and are widely used to manage heart conditions like atrial fibrillation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for atrial fibrillation, which often involves medications like beta-blockers and anticoagulants, or invasive procedures like catheter ablation, the insertable cardiac monitor (ICM) offers a novel approach by continuously recording the heart’s electrical activity. This device is unique because it can be implanted to provide precise, daily data transmission for arrhythmia detection, allowing for real-time monitoring without the need for frequent doctor visits. Researchers are excited about this because the ICM could lead to more timely interventions and personalized management of atrial fibrillation, potentially catching issues before they escalate. Additionally, for those who prefer non-invasive options, the Carnation Ambulatory Monitor (CAM™) provides a patch-based long-term ECG monitoring alternative, applied to the skin, that can offer similar insights.

What evidence suggests that this insertable cardiac monitor is effective for atrial fibrillation?

Research has shown that insertable cardiac monitors (ICMs), one of the treatment options in this trial, can help manage atrial fibrillation (AF), a type of irregular heartbeat. One study found that these monitors detected real heart rhythm problems in 45.7% of patients, leading to important medical treatments. The monitors provide clear and useful information, assisting doctors in identifying arrhythmias that are difficult to detect. The latest ICMs are highly reliable, with a sensitivity rate of over 98%, making them excellent at spotting these heart rhythm issues. Overall, ICMs are promising tools for reducing the impact of AF by aiding in better management and treatment choices. ^{1 2 5 6 7}

Who Is on the Research Team?

Ilan Goldenberg, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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.

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

History of paroxysmal atrial fibrillation per 2019 HRS guidelines definition or history of persistent atrial fibrillation per 2019 HRS guidelines definition

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Insertable Cardiac Monitor

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The Reveal LINQ insertable cardiac monitor (ICM) demonstrated a high positive predictive value for detecting atrial fibrillation (AF), with values of 84% for all episodes and up to 97% for episodes lasting at least one hour in patients with syncope, known AF, and cryptogenic stroke, based on a study of 3759 patients.

The study found that limiting ECG storage to the longest detected AF episode reduced the workload for reviewing episodes without significantly affecting the detection of true AF cases, indicating an efficient monitoring strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world performance of an enhanced atrial fibrillation detection algorithm in an insertable cardiac monitor. Mittal, S., Rogers, J., Sarkar, S., et al.[2022]

The Jot Dx™ is a new Bluetooth-enabled insertable cardiac monitor that allows for continuous heart rhythm monitoring and immediate data transmission to physicians, enhancing patient care.

This report highlights the successful implantation of the Jot Dx™ in a pediatric patient weighing only 11.7 kg, demonstrating its applicability and safety in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful modified implantation of insertable cardiac monitor in a very young paediatric patient. Srivastava, NS., Arruda, J., Haddadin, CA., et al.[2023]

The new generation insertable cardiac monitor (ICM) showed an excellent safety profile, with a 99.4% freedom from serious adverse device and procedure-related events within the first month for 1400 enrolled subjects.

The ICM demonstrated high clinical value, detecting true cardiac arrhythmias in 45.7% of patients during a 6-month monitoring period, leading to significant interventions such as pacemaker implants and anticoagulation therapy, while 78.2% of patients reported satisfaction with the remote monitoring app.

NCBI (Pubmed)

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. Quartieri, F., Harish, M., Calò, L., et al.[2023]

Implantable loop recorders (ILRs) are considered the gold standard for detecting atrial fibrillation (AF), offering superior diagnostic capabilities compared to other monitoring methods.

ILRs not only help in diagnosing AF but are also useful for monitoring patients after AF ablation, although more research is needed to clarify how the detection of AF via ILRs should influence treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable loop recorders in patients with atrial fibrillation. Sharma, AN., McIntyre, WF., Nguyen, ST., et al.[2022]

The Reveal LINQ™ Insertable Cardiac Monitor (ICM) is effective for long-term monitoring of potentially dangerous heart conditions, such as complete heart block (CHB), in young children, as demonstrated in a case of a 20-month-old boy with increasing pause lengths in heart rhythm.

This device allows for continuous ECG recording for up to 3 years, which helps in diagnosing arrhythmias and making informed decisions about treatments like pacemaker implantation, highlighting its safety and efficacy in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first case of the Reveal LINQ™ Insertable Cardiac Monitor implanted in a child in Malta. Aquilina, A., Aquilina, O., Sammut, M., et al.[2022]

Patients with insertable cardiac monitors (ICMs) after atrial fibrillation (AF) ablation experienced significantly fewer severe cardiovascular events and lower associated healthcare costs compared to those without ICMs, indicating improved patient outcomes with long-term monitoring.

ICM patients had more frequent AF-related clinic visits and a higher likelihood of receiving repeat ablation, suggesting that continuous monitoring allows for better management of AF, although they also showed a higher rate of discontinuation of oral anticoagulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare utilization and clinical outcomes after ablation of atrial fibrillation in patients with and without insertable cardiac monitoring. Mansour, MC., Gillen, EM., Garman, A., et al.[2022]

The insertable cardiac monitor (ICM) has a low incidence of procedure-related adverse events, with infections occurring in only 1.3% of patients in a usability study and 1.6% in a real-world registry.

The safety profile of the ICM was confirmed through two studies involving a total of 273 patients, indicating that it can be safely used for continuous monitoring of arrhythmias with minimal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two Prospective Trials. Mittal, S., Sanders, P., Pokushalov, E., et al.[2022]

Citations

1. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/cardiac-rhythm-management/insertable-cardiac-monitors/assert-iq-icm.html

About Assert-IQ Insertable Cardiac Monitor Loop Recorder Detected High Rate of Atrial Fibrillation Recurrence after a Single Balloon- or Basket-Based Ablation of Paroxysmal Atrial Fibrillation ...

2. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/cardiac-rhythm-management/insertable-cardiac-monitors/jot-dx.html

Jot Dx ICM Overview Jot Dx Insertable Cardiac Monitor (ICM) gives you the precise, actionable EGM insights you need to accurately diagnose difficult-to-detect arrhythmias.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666501825004131

Real-world Use of Insertable Cardiac Monitor Remote ... The LUX-Dx™ is a small ICM designed to monitor, record, and store data related to cardiac arrhythmias that fall into five categories: pauses, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10227665/

New insertable cardiac monitors show high diagnostic yield ... In the 6-month monitoring period, the ICM detected true cardiac arrhythmias in 45.7% of patients and led to clinical interventions in a relevant ...

5. academic.oup.com academic.oup.com/europace/article/26/1/euad375/7505492

Improved diagnostic performance of insertable cardiac ... The new AI-based ILR-ECG-A lowered the rate of FP ICM diagnoses significantly while retaining a > 98% sensitivity. This will likely alleviate ...

6. bostonscientific.com bostonscientific.com/us/en/healthcare-professionals/products/cardiac-monitors/lux-dx-iiplus-insertable-cardiac-monitor-icm-system/fp90000113.html

LUX-Dx II+™ Insertable Cardiac Monitor (ICM) System LUX-Dx II+ ICM System (also known as a loop recorder) uses enhanced dual-stage algorithms that detect and then verify data before sending ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1547527110012038

Safety and reliability of the insertable Reveal XT recorder ... Up to now there is little evidence about the safety and reliability of insertable cardiac monitors (ICMs) in patients undergoing magnetic resonance imaging ...