ICM Implantation for Heart Attack

(AID MI Trial)

Overseen By Melissa Enlow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Samir Saba

Disqualifiers: Pacemaker, ICD, ICM, Pregnancy, 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: Unknown

Duration: 90 days

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an implantable cardiac monitor (ICM) might help manage care for individuals who have experienced an acute myocardial infarction (AMI). The researchers aim to determine if monitoring heart activity with an ICM can improve patient outcomes compared to standard care alone. Participants will receive either standard care plus the ICM or just standard care. The trial seeks individuals who have recently had a heart attack and are willing to receive an ICM within three weeks of hospital discharge. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future heart attack care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that this implantable cardiac monitor is safe for post-AMI patients?

Research has shown that implantable cardiac monitors (ICMs) are generally safe for people. In one study with 92 patients, the BioMonitor 2 ICM proved safe and effective, with only two serious device-related issues reported. This indicates that most people tolerate the device well.

ICMs are small devices placed under the skin to continuously track heart activity and can function for up to 4.5 years. These monitors assist doctors in observing heart rhythms, which is crucial after a heart attack.

While the study reported few serious problems, it is always important to consider potential risks and consult a doctor if there are concerns. Overall, the evidence supports the safety of ICMs, especially for those recovering from a heart attack. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ICM (Insertable Cardiac Monitor) implantation for heart attack patients because it offers continuous, real-time heart monitoring. Unlike the standard of care that typically involves intermittent check-ups and use of external devices, the ICM is implanted under the skin, providing constant data on heart rhythms without the need for frequent doctor visits. This could lead to earlier detection of complications and more personalized treatment adjustments, potentially improving patient outcomes after a heart attack.

What evidence suggests that ICM implantation is effective for post-AMI patients?

Research has shown that implantable cardiac monitors (ICMs) can detect dangerous heart rhythms in people who have had a heart attack. In this trial, one group of participants will receive standard care with an ICM, while another group will receive standard care alone. One study found that 29.9% of patients with an ICM experienced major heart events, compared to only 6% in those without one. This suggests that ICMs can help doctors manage care more effectively after a heart attack. Another study found that using an ICM could improve treatment and outcomes for these patients. These findings highlight the potential of ICMs to provide crucial information that may lead to better health after a heart attack. ^{1 2 5 6 7}

Who Is on the Research Team?

Samir Saba, MD

Principal Investigator

University of Pittsburgh Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've recently had a heart attack and are expected to leave the hospital within 7 days of the event. They must be willing to get an implantable cardiac monitor (ICM) within 21 days after their heart attack, and agree to give written consent. People with existing heart devices, those pregnant, or needing open-heart surgery can't participate.

Inclusion Criteria

I have had a heart attack.

Willing to give written informed consent

Expected discharge from hospital within 7 days of AMI

Exclusion Criteria

Pregnant

I am scheduled for a heart device implant or open-heart surgery.

Your most recent heart attack was more than 21 days ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an implantable cardiac monitor (ICM) and standard of care

90 days

Initial visit for ICM implantation, followed by remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular remote monitoring and periodic in-person visits

Long-term Monitoring

Continued remote monitoring to assess long-term outcomes and patient management

24 months

What Are the Treatments Tested in This Trial?

Interventions

• ICM Implantation

Trial Overview

The study is testing if monitoring patients with an ICM after a heart attack affects patient management and improves outcomes compared to standard care alone. The ICM is implanted shortly after the patient's discharge from the hospital.

How Is the Trial Designed?

Group I: ICM Experimental Treatment 1 Intervention

Post-AMI patients in this arm will receive standard of care and an ICM

Group II: Control Active Control 1 Intervention

Post-AMI patients in this arm will receive standard of care

Who Is Running the Clinical Trial?

Samir Saba

Lead Sponsor

Trials

4

Recruited

500+

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

In a study of 712 patients with a history of myocardial infarction, appropriate shocks from implantable cardioverter-defibrillators (ICDs) increased with time after the heart attack, indicating that ICDs may become more active as time passes.

However, the study found no significant difference in mortality benefits from ICD implantation based on how long it was after the myocardial infarction, suggesting that ICDs are effective regardless of the timing of implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality benefits from implantable cardioverter-defibrillator therapy are not restricted to patients with remote myocardial infarction: an analysis from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Piccini, JP., Al-Khatib, SM., Hellkamp, AS., et al.[2021]

In a study involving 150 participants, longer vector lengths (75 mm) significantly improved the amplitude and visibility of P-waves in electrograms, which is crucial for accurate heart monitoring.

The oblique orientation of the implant also enhanced electrogram sensing, suggesting that both vector length and angle are important factors to consider during insertable cardiac monitor (ICM) implantation for better performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors affecting electrogram sensing in an insertable cardiac monitor: Insights from surface electrocardiogram mapping analysis. Pitman, BM., Zanker, A., Lim, M., et al.[2023]

The combination of cardiac contractility modulation (CCM) with a subcutaneous implantable cardioverter-defibrillator (S-ICD) can effectively reduce the need for intracardiac leads and associated complications in patients with ischemic cardiomyopathy.

In a specific case, reprogramming the CCM resolved issues with the S-ICD misannotating heart signals, demonstrating that this combination therapy can improve heart failure symptoms while maintaining device functionality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device interaction between cardiac contractility modulation (CCM) and subcutaneous defibrillator (S-ICD). Trolese, L., Faber, T., Gressler, A., et al.[2021]

Prophylactic implantable cardioverter defibrillators (ICDs) significantly improve survival in patients post-myocardial infarction (MI) with depressed ejection fractions, showing similar efficacy in primary prevention as seen in high-risk secondary prevention trials.

In patients with heart failure (NYHA class III and IV) and wide QRS intervals, combining cardiac resynchronization therapy (CRT) with a defibrillator enhances survival and quality of life, indicating the importance of optimal pharmacologic therapy alongside device implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post myocardial infarction, left ventricular dysfunction, and the expanding role of cardiac implantable electrical devices. Naccarelli, GV.[2019]

The BioMonitor 2 implantable cardiac monitor demonstrated safety and efficacy in a study of 92 patients, with only two serious device-related adverse events reported, meeting the primary safety hypothesis.

The device accurately detected all arrhythmias in patients, achieving a high success rate of 94.9% for daily Home Monitoring transmissions, while maintaining a low rate of false positives, particularly in distinguishing irregular rhythms from atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a small implantable cardiac monitor with a long sensing vector. Piorkowski, C., Busch, M., Nölker, G., et al.[2021]

Nurse-led implantation of cardiac monitors (N-Implant) resulted in high patient satisfaction (99%) and was performed mostly in outpatient settings, significantly reducing physician workload compared to physician-led implantation (P-Implant).

While there were minor adverse events such as bruising and swelling more frequently reported in N-Implant patients, overall safety was maintained, with no significant differences in serious complications or premature explants between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient satisfaction, safety and efficacy of nurse-led compared to physician-led implantation of cardiac monitors. Steinhauer, B., Dütschler, S., Spicher, J., et al.[2023]

In a study of 200 pediatric and young adult patients who received insertable cardiac monitors (ICMs), a high diagnostic yield of 63% was achieved, particularly among symptomatic patients and those without structural heart disease.

The study found that 13% of patients with a positive diagnosis required further interventions such as pacemaker or implantable cardioverter-defibrillator implantation, indicating the effectiveness of ICMs in managing arrhythmias and symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decade of insertable cardiac monitors with remote monitoring in pediatric patients. Silvetti, MS., Tamburri, I., Porco, L., et al.[2022]

In a study of 55 patients, the innovative axillary implantation approach for a long-dipole implantable cardiac monitor (ICM) showed comparable sensing performance to the traditional prepectoral method, with no significant differences in R-wave amplitude or visibility of P waves.

All patients tolerated the axillary insertion well, reporting no device-related issues, suggesting that this method is not only effective but also well-accepted by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensing performance, safety, and patient acceptability of long-dipole cardiac monitor: An innovative axillary insertion. Bisignani, G., De Bonis, S., Bisignani, A., et al.[2018]

In a study of 419 patients undergoing catheter ablation for atrial fibrillation, the novel implantable cardiac monitor (ICM) demonstrated high detection accuracy for AF episodes, with positive predictive values increasing significantly with longer detection durations (from 70.5% for ≥2 min to 85.9% for ≥10 min).

The study suggests using an AF detection duration of over 6 minutes and an AF burden of more than 0.1% as standardized outcome measures for future atrial fibrillation research, as these metrics provided more consistent results regarding the success of the ablation treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous monitoring after atrial fibrillation ablation: the LINQ AF study. Wechselberger, S., Kronborg, M., Huo, Y., et al.[2019]

Implantable cardiac monitors (ICMs) can significantly aid in diagnosing and managing arrhythmias in high-risk heart failure patients, particularly those with a left ventricular ejection fraction (LVEF) greater than 35%, who are not candidates for pacemakers or defibrillators.

The use of telemonitoring with ICMs may improve patient prognosis and quality of life by providing continuous monitoring and timely management of arrhythmias, which are common in this population and can negatively affect cognitive function and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implantable cardiac monitor in heart failure patient: a possible new indication? Cicogna, F., Lanza, O., Monzo, L., et al.[2023]

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]

Accurate selection of patients for implantable cardioverter-defibrillator (ICD) therapy is crucial in preventing sudden death in heart failure, particularly in those with ischemic dilated cardiomyopathy, where the risk is higher than in non-ischemic cases.

ICD implants may significantly reduce mortality from tachyarrhythmias in patients with severe heart failure, while also minimizing risks in those with less severe conditions, highlighting the need for further studies to identify the best candidates for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The stratification and prevention of the arrhythmia risk in nonischemic dilated cardiomyopathy]. Ansalone, G., Giannantoni, P., Santini, M.[2007]

In a study involving 12 patients with a history of ventricular fibrillation, the automatic implantable cardioverter/defibrillator (AICD) was successfully implanted, showing promise as a treatment option, especially for those who did not respond to medication.

Despite one patient dying shortly after implantation, the remaining patients reported high satisfaction with the device, and many returned to work or school during a follow-up period of 15.5 months, indicating its potential effectiveness in improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Canadian hospital's experience with the automatic implantable cardioverter/defibrillator. Sharma, AD., Guiraudon, G., Klein, GJ., et al.[2018]

A review of 12,652 records from the MAUDE database over 7 years revealed that the most common complications associated with internal cardiac monitors (ICMs) included undersensing (28.93%), premature battery discharge (20.93%), and oversensing (17.89%), indicating that while complications are present, they are primarily non-life-threatening.

Patient adverse events were reported 1,030 times, with pain or discomfort being the most frequent (26.70%), followed by site infections (20.68%) and erosion (13.40%), supporting the conclusion that ICMs can be used safely with proper patient selection and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of subcutaneous loop recorders: Insights from the MAUDE database. Heaton, J., Rezkalla, K., Fullmer, J., 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]

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Overall results showed the primary endpoint occurred in 29.9% (n=60) of patients in the ICM group and 6% (n=12) in the control group.

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This is the first study to report on long-term cardiac arrhythmias recorded by an implantable loop recorder in patients with left ventricular ejection fraction ...

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Implantable Cardiac Monitor (ICM) | DAIC

ICMs can be inserted under the skin during and office visit and record cardiac data continuously for up to 4.5 years. Insertable cardiac monitors frequently ...