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

Trial Summary

What is the purpose of this trial?

Patients post acute myocardial infarction (AMI) have a high risk of mortality but the use of an implantable defibrillator in the early aftermath of an AMI has not been shown to improve patients' survival. The VEST trial recently demonstrated an improved overall survival in post AMI patients with the use of a wearable defibrillator. The same improvement was not demonstrated for the risk of sudden cardiac death. Monitoring patients after AMI using an implantable cardiac monitor (ICM) may document findings that can impact patient management and eventually improve their outcomes. We are therefore conducting the AID MI trial to examine the impact of ICM on patient management in the post AMI setting.

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 data supports the effectiveness of the treatment ICM Implantation for Heart Attack?

Research shows that implantable cardiac monitors (ICMs) are effective in managing heart rhythm problems and improving patient outcomes in heart failure and arrhythmia cases. They help in early detection and management of heart rhythm issues, which can improve quality of life and reduce healthcare costs. ^{1 2 3 4 5}

Is ICM implantation generally safe for humans?

ICM implantation is generally considered safe, with complications reported at a low rate. Studies have shown that the procedure is minimally invasive, and both nurse-led and physician-led implantations have been evaluated for safety. ^{6 7 8 9 10}

How does ICM Implantation for Heart Attack differ from other treatments?

ICM (Implantable Cardioverter-Defibrillator) implantation is unique because it provides a preventive therapy for patients at risk of sudden cardiac death after a heart attack by automatically detecting and correcting life-threatening heart rhythms, unlike standard drug therapies that may not address these specific arrhythmias. ^{11 12 13 14 15}

Research Team

Samir Saba, MD

Principal Investigator

University of Pittsburgh Medical Center

Eligibility Criteria

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 am 18 years old or older.

I have had a heart attack.

Willing to give written informed consent

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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 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]

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 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]

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 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 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]

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]

References

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

Factors affecting electrogram sensing in an insertable cardiac monitor: Insights from surface electrocardiogram mapping analysis. [2023]

2. Singapore pubmed.ncbi.nlm.nih.gov

A decade of insertable cardiac monitors with remote monitoring in pediatric patients. [2022]

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

Sensing performance, safety, and patient acceptability of long-dipole cardiac monitor: An innovative axillary insertion. [2018]

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

Continuous monitoring after atrial fibrillation ablation: the LINQ AF study. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The implantable cardiac monitor in heart failure patient: a possible new indication? [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Complications after implantation of a new-generation insertable cardiac monitor: Results from the LOOP study. [2018]

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

Clinical evaluation of a small implantable cardiac monitor with a long sensing vector. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Patient satisfaction, safety and efficacy of nurse-led compared to physician-led implantation of cardiac monitors. [2023]

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

A single center experience on the clinical utility evaluation of an insertable cardiac monitor. [2019]

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

Adverse events of subcutaneous loop recorders: Insights from the MAUDE database. [2022]

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

Device interaction between cardiac contractility modulation (CCM) and subcutaneous defibrillator (S-ICD). [2021]

12. Italy pubmed.ncbi.nlm.nih.gov

[The stratification and prevention of the arrhythmia risk in nonischemic dilated cardiomyopathy]. [2007]

13. United States 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). [2021]

14. Canada pubmed.ncbi.nlm.nih.gov

A Canadian hospital's experience with the automatic implantable cardioverter/defibrillator. [2018]

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

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