Insertable Cardiac Monitor for Atrial Fibrillation Detection in Heart Failure Patients

(ASSERT-AF Trial)

Overseen By Mary Bourret

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must be taking: Loop diuretics

Disqualifiers: ICD, Pacemaker, AF history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

477 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people with heart failure by detecting atrial fibrillation (AF) early using a small device called an insertable cardiac monitor (ICM). Placed under the skin, the ICM tracks heart rhythms over time and sends the information to doctors through a smartphone app. The trial compares this ICM with usual methods to determine if it can better detect AF and other heart issues early. Individuals with heart failure who are on certain diuretics and experience symptoms like dizziness or chest pain might be suitable for this study. Participants must be willing to have the ICM implanted and agree to remote monitoring. As an unphased trial, this study offers a unique opportunity to contribute to innovative research aimed at improving heart failure 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 heart failure patients?

Research has shown that the Confirm Rx Insertable Cardiac Monitor (ICM) is generally well-tolerated by patients. The FDA-approved device is placed under the skin to detect heart rhythm problems. Studies have found that it accurately identified real heart rhythm issues in about 45.7% of patients. Importantly, these studies reported no major safety concerns. For instance, the device has helped guide treatments, such as deciding when to implant pacemakers, which can improve patient outcomes. This suggests the device is safe for those who need heart monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Confirm Rx Insertable Cardiac Monitor because it offers a new way to detect atrial fibrillation in heart failure patients. Unlike traditional methods, which rely on observing symptoms, this tiny device is implanted under the skin and can continuously monitor the heart's activity over a long period. It connects to a smartphone app called My Merlin, allowing for rapid and remote review of heart data. This approach could lead to earlier detection and management of arrhythmias, potentially improving patient outcomes more effectively than conventional management methods.

What evidence suggests that the ASSERT insertable cardiac monitor is effective for detecting atrial fibrillation in heart failure patients?

Research shows that the Confirm Rx Insertable Cardiac Monitor (ICM), which participants in this trial may receive, effectively detects atrial fibrillation (AF) in patients. Studies have found that it correctly identifies heart rhythm problems in about 45.7% of patients. This detection can lead to important medical decisions, such as the need for a pacemaker in some cases. Patients using the ICM are more likely to have AF detected than with traditional methods. Early detection can lead to better health by allowing quicker treatment. The ICM works with a smartphone app, providing doctors with real-time information for improved patient care. ^{1 3 4 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 over 18 with heart failure who've had a recent exacerbation treated in hospital, have an ejection fraction over 35%, and are at risk for arrhythmias but haven't been diagnosed with atrial fibrillation. They must be willing to get a Confirm Rx monitor implanted and agree to remote monitoring. Those with existing heart devices or unwilling to follow the protocol can't join.

Inclusion Criteria

I experience symptoms like dizziness or chest pain, or am at risk for heart rhythm problems.

I am over 18 years old.

My heart's pumping ability is above 35% as shown in a recent heart scan.

Exclusion Criteria

Participation in other clinical trials (observational registries are allowed with approval from the Coordination Center)

You have a device implanted in your heart, such as a defibrillator or pacemaker.

Unable or unwilling to sign the consent for participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

ICM Implantation and Initial Monitoring

Participants receive the ASSERT implantable cardiac monitor (ICM) and begin remote monitoring for arrhythmia detection

4 weeks

1 visit (in-person) for device implantation, followed by remote monitoring

Long-term Monitoring

Participants are monitored for arrhythmias and other cardiac events using the ICM and remote monitoring system

24 months

Remote monitoring with periodic in-person follow-ups as needed

Follow-up

Participants are monitored for safety and effectiveness after the main monitoring period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Confirm Rx Insertable Cardiac Monitor

Trial Overview The study is testing if using the Confirm Rx Insertable Cardiac Monitor can better detect atrial fibrillation early in high-risk heart failure patients compared to standard care. The device is placed under the skin and tracks heart rhythms remotely over time.

How Is the Trial Designed?

Group I: ASSERT insertable cardiac monitor Experimental Treatment 1 Intervention

The ASSERT implantable cardiac monitor (ICM) is an FDA-approved device that can be injected into the subcutaneous tissue and can provide automatic as well as patient triggered electrocardiographic recordings of symptomatic episodes during long term follow-up. This Implantable cardiac monitor is paired with a remote monitoring smartphone application called My Merlin that capable of rapid remote review of electrograms to be utilized in this study for arrhythmia detection. The ASSERT ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

Group II: Conventional Management Active Control 1 Intervention

The conventional management arm will use arrhythmia signs and symptoms to determine occurrence of arrhythmias.

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

Approved in United States as Confirm Rx ICM for:

• Primary atrial fibrillation detection in high-risk heart failure patients

Approved in European Union as Confirm Rx ICM for:

• Detection of atrial fibrillation and other arrhythmias in high-risk heart failure patients

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

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 Confirm DM2102 implantable cardiac monitor (ICM) demonstrated 100% sensitivity in detecting atrial fibrillation (AF) in a study of 79 patients, indicating it can reliably identify AF episodes lasting at least 2 minutes.

The ICM also showed high specificity (85.7%) and negative predictive value (100%), suggesting it is effective for continuous monitoring and can help in clinical decision-making regarding AF management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. Nölker, G., Mayer, J., Boldt, LH., et al.[2022]

This report highlights the successful implantation of the Bluetooth™-enabled Confirm RX™ insertable cardiac monitor in a 17-year-old patient, marking a significant advancement in pediatric cardiac care.

The device allows for immediate access to heart rhythm data after a minimally invasive procedure, which can be crucial for diagnosing unexplained syncopal episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confirm RX™ Cardiac Monitor Placement in a Pediatric Patient. Kilinc, OU., Shivapour, JKL., Snyder, CS.[2020]

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 Reveal LINQ™ insertable cardiac monitor (ICM) has a very low complication rate, with only 0.63% of patients experiencing adverse events (AEs) requiring explantation during a median follow-up of 499 days.

Patients implanted in outpatient procedure rooms had a higher rate of infections compared to those in electrophysiology laboratories, but overall, the ICM can be safely implanted in both settings with minimal risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications after implantation of a new-generation insertable cardiac monitor: Results from the LOOP study. Diederichsen, SZ., Haugan, KJ., Højberg, S., et al.[2018]

In a study of 95 patients using the Reveal LINQ™ insertable cardiac monitor (ICM) over a median follow-up of 414 days, the device demonstrated significant clinical utility, identifying both expected and unexpected findings in nearly half of the patients (48.4%).

The ICM detected atrial fibrillation in 31.6% of patients with cryptogenic stroke and led to therapeutic interventions in 18.9% of patients, highlighting its effectiveness in diagnosing arrhythmias and guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single center experience on the clinical utility evaluation of an insertable cardiac monitor. Li, Y., Nantsupawat, T., Olson, M., et al.[2019]

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]

The insertable cardiac monitor (ICM) significantly improves the detection rate of atrial fibrillation (AF) in stroke patients, with detection rates being 4.63 times higher at 6 months and 5.04 times higher at 12 months compared to control groups, based on a review of 1233 patients from three randomized controlled trials.

While the ICM group had a higher rate of oral anticoagulant usage, it also experienced more adverse events compared to the control group, indicating a need for further development to reduce these negative effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of insertable cardiac monitor on atrial fibrillation detection in patients with ischemic stroke: a systematic review and meta-analysis. Tan, X., Wang, Z., Wu, X., et al.[2022]

Insertable cardiac monitors (ICMs) are effective for diagnosing unexplained recurrent syncope and detecting atrial fibrillation (AF) in patients after cryptogenic stroke, based on evidence from multiple randomized controlled trials involving over 1,600 participants.

ICMs demonstrated a significantly higher diagnostic yield compared to conventional monitoring methods, making them a valuable tool for identifying arrhythmias in these patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insertable cardiac monitors in the diagnosis of syncope and the detection of atrial fibrillation: A systematic review and meta-analysis. Burkowitz, J., Merzenich, C., Grassme, K., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36436199/

Confirm Rx insertable cardiac monitor for primary atrial ... A finding showing significantly higher incidence of AF along with improved clinical outcomes with ICM monitoring is expected to have substantial clinical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9833354/

Confirm Rx insertable cardiac monitor for primary atrial ... A finding showing significantly higher incidence of AF along with improved clinical outcomes with ICM monitoring is expected to have substantial ...

3. cardiovascular.abbott cardiovascular.abbott/int/en/hcp/products/cardiac-rhythm-management/insertable-cardiac-monitors/confirm-rx/clinical-evidence/articles.html

Confirm Rx ICM Journal Articles It effectively identified true cardiac arrhythmias in 45.7% of patients, leading to significant clinical actions such as pacemaker implants in 8.9% of syncope ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03505801?utm_source=trialradar

Confirm Rx Insertable Cardiac Monitor SMART Registry The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable ...

5. jacc.org jacc.org/doi/10.1016/S0735-1097%2824%2904640-0

A RETROSPECTIVE STUDY OF FEDERAL DATABASE EFFECTIVENESS OF SMARTPHONE-BASED REMOTE MONITORING USING THE CONFIRM RX™ INSERTABLE CARDIAC MONITOR - A RETROSPECTIVE STUDY OF FEDERAL DATABASE.

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/anec.13021

Confirm Rx insertable cardiac monitor for primary atrial ... The Confirm-AF trial seeks to accurately define the burden of AF in high-risk HF patients with LVEF > 35% using an Abbott ICM.

7. researchgate.net researchgate.net/publication/365784960_Confirm_Rx_insertable_cardiac_monitor_for_primary_atrial_fibrillation_detection_in_high-risk_heart_failure_patients_Confirm-AF_trial

(PDF) Confirm Rx insertable cardiac monitor for primary ... An implantable cardiac monitor (ICM) is inserted subcutaneously and can provide long‐term arrhythmia information via remote monitoring. Methods and Results ...