Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients

NCT04818645 | Active Not Recruiting DMC FDA Device

• 1 other identifier: STUDY00007311
• Study Type: interventional
• Target: 477
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with heart failure (HF) represent a large population of patients who are at high risk for complications related to undiagnosed atrial fibrillation (AF). However, currently there are limited modalities for early AF detection and subsequent stroke prevention in this high-risk population. An implantable cardiac monitor (ICM) is inserted subcutaneously and can provide long term arrhythmia information via remote monitoring. The ASSERT-AF study seeks to accurately define the burden of AF and other arrhythmias in high-risk HF patients using an ASSERT ICM.

Conditions

Atrial Fibrillation; Heart Failure

Keywords

Implantable cardiac monitor; Atrial fibrillation; Heart failure; Remote monitoring; Stroke

Outcome Measures

Primary Outcomes (1)

• Median Time to first detection of AF lasting > 5 minutes

  Defined as ICM detected AF in the intervention (implantable cardiac monitor) arm or captured by clinical symptoms and documented by ECG or Holter in the conventional arm.

  24 months

Secondary Outcomes (6)

• Time to initiation of guideline directed anti-arrhythmic and HF interventions

  24 months

• Number cardiovascular hospitalizations or death

  24 months

• Compare healthcare utilization using Abbott ICM vs. non-ICM monitoring.

  24 months

• Mean quality of life measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  24 months

• Mean percentage of time spent in atrial fibrillation (AF Burden)

  24 months

Other Outcomes (3)

• Compare the effect of patient-triggered transmissions on the time to Abbott ICM detection of arrhythmic events triggered by symptomatic recordings versus automatically detected arrhythmic event recordings.

  24 months

• Evaluate the rate of actionable interventions following symptom triggered event versus the rate of actionable interventions associated with automatic detected arrhythmic events.

  24 months

• Correlate ICM interrogation data relating to heart sounds, body posture, activity, sleep detection and heart rate variability, with the risk of new heart failure events.

  24 months

Study Arms (2)

ASSERT insertable cardiac monitor

EXPERIMENTAL

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.

Device: ASSERT Insertable Cardiac Monitor

Conventional Management

ACTIVE COMPARATOR

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

Other: Conventional Management and monitoring

Interventions

ASSERT Insertable Cardiac Monitor DEVICE

Subjects will be subcutaneously implanted with an Abbott ASSERT ICM with the device implant procedure per standard of care and current labelling. Data related to subjects' arrhythmias, via the Merlin.net Patient CareNetwork will be transmitted on a monthly basis to the treating physician and subsequently to the study coordination and database center (CCRC) at the University of Rochester. Data on the frequency/types of symptomatic (patient triggered) versus ICM detected (asymptomatic) arrhythmic events will be collected and adjudicated. Clinical data on medication, device interventions, cardiovascular events will be collected at follow-up visits.

ASSERT insertable cardiac monitor

Conventional Management and monitoring OTHER

Subjects randomized to the conventional management arm of the trial will undergo arrhythmia monitoring based on clinical indications and per standard available modalities including periodic electrocardiograms (ECG), Holter and/or event monitoring.

Conventional Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients more than 18 years of age (no upper age limit)
• HF exacerbation requiring initiation or augmentation of decongestive therapy in a hospital setting (hospitalization or emergency department visit) during the past 24 calendar months prior to consent date OR current treatment with loop-diuretics (furosemide, bumetanide, or torsemide).
• LVEF \> 35% on a cardiac imaging study (echocardiogram, nuclear imaging, cardiac magnetic resonance imaging) performed during the past 24 calendar months prior to consent date
• One or more FDA-approved indications for an Abbott ICM (unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias).
• Willing to undergo an Abbott ICM implant and agree to remote ICM monitoring.

You may not qualify if:

• Existing implantable cardioverter defibrillator (ICD), biventricular ICD, implantable cardiac monitor or pacemaker.
• Known or documented history AF or atrial flutter any time in past.
• Has had a heart transplant
• Participation in other clinical trials (observational registries are allowed with approval from the Coordination Center)
• Unable or unwilling to cooperate with the protocol
• Unable or unwilling to sign the consent for participation

Sponsors & Collaborators

• Abbott: collaborator
• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (13)

• Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.

  PMID: 11343485 BACKGROUND

• Kannel WB, Wolf PA, Benjamin EJ, Levy D. Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: population-based estimates. Am J Cardiol. 1998 Oct 16;82(8A):2N-9N. doi: 10.1016/s0002-9149(98)00583-9.

  PMID: 9809895 BACKGROUND

• Lin HJ, Wolf PA, Kelly-Hayes M, Beiser AS, Kase CS, Benjamin EJ, D'Agostino RB. Stroke severity in atrial fibrillation. The Framingham Study. Stroke. 1996 Oct;27(10):1760-4. doi: 10.1161/01.str.27.10.1760.

  PMID: 8841325 BACKGROUND

• Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013 Oct 15;112(8):1142-7. doi: 10.1016/j.amjcard.2013.05.063. Epub 2013 Jul 4.

  PMID: 23831166 BACKGROUND

• Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Abhayaratna WP, Seward JB, Tsang TS. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006 Jul 11;114(2):119-25. doi: 10.1161/CIRCULATIONAHA.105.595140. Epub 2006 Jul 3.

  PMID: 16818816 BACKGROUND

• Lin HJ, Wolf PA, Benjamin EJ, Belanger AJ, D'Agostino RB. Newly diagnosed atrial fibrillation and acute stroke. The Framingham Study. Stroke. 1995 Sep;26(9):1527-30. doi: 10.1161/01.str.26.9.1527.

  PMID: 7660392 BACKGROUND

• Anter E, Jessup M, Callans DJ. Atrial fibrillation and heart failure: treatment considerations for a dual epidemic. Circulation. 2009 May 12;119(18):2516-25. doi: 10.1161/CIRCULATIONAHA.108.821306. No abstract available.

  PMID: 19433768 BACKGROUND

• Trulock KM, Narayan SM, Piccini JP. Rhythm control in heart failure patients with atrial fibrillation: contemporary challenges including the role of ablation. J Am Coll Cardiol. 2014 Aug 19;64(7):710-21. doi: 10.1016/j.jacc.2014.06.1169.

  PMID: 25125304 BACKGROUND

• Maisel WH, Stevenson LW. Atrial fibrillation in heart failure: epidemiology, pathophysiology, and rationale for therapy. Am J Cardiol. 2003 Mar 20;91(6A):2D-8D. doi: 10.1016/s0002-9149(02)03373-8.

  PMID: 12670636 BACKGROUND

• Pellicori P, Urbinati A, Kaur K, Zhang J, Shah P, Kazmi S, Capucci A, Cleland JGF, Clark AL. Prevalence and Incidence of Atrial Fibrillation in Ambulatory Patients With Heart Failure. Am J Cardiol. 2019 Nov 15;124(10):1554-1560. doi: 10.1016/j.amjcard.2019.08.018. Epub 2019 Aug 23.

  PMID: 31558271 BACKGROUND

• Ducharme A, Swedberg K, Pfeffer MA, Cohen-Solal A, Granger CB, Maggioni AP, Michelson EL, McMurray JJ, Olsson L, Rouleau JL, Young JB, Olofsson B, Puu M, Yusuf S; CHARM Investigators. Prevention of atrial fibrillation in patients with symptomatic chronic heart failure by candesartan in the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) program. Am Heart J. 2006 Jul;152(1):86-92.

  PMID: 16838426 BACKGROUND

• Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Wachter R, Pouliot E, Ziegler PD; REVEAL AF Investigators. Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study. JAMA Cardiol. 2017 Oct 1;2(10):1120-1127. doi: 10.1001/jamacardio.2017.3180.

  PMID: 28842973 BACKGROUND

• Beinart SC, Natale A, Verma A, Amin A, Kasner S, Diener HC, Pouliot E, Franco N, Mittal S. Real-World Use of Prophylactic Antibiotics in Insertable Cardiac Monitor Procedures. Pacing Clin Electrophysiol. 2016 Aug;39(8):837-42. doi: 10.1111/pace.12886. Epub 2016 Jun 7.

  PMID: 27198480 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Ilan Goldenberg, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Events Review Committee: A blinded three-member Events Review Committee will review de-identified source documents obtained from each of the enrolling sites that will only be labelled with a subject ID. No data will be provided indicating the randomized treatment arm to the study and appropriately redacted with no ICM data provided. The information will be used to determine the nature of any clinical and adverse events. Available medical records and source documents will be used to determine cause-specific mortality.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Subjects will be randomized in a 2:1 fashion to undergo implant of an ASSERT ICM implant with remote monitoring and symptom-triggered mobile app transmissions versus conventional follow-up without an ICM. Randomization will be stratified by the degree of LV dysfunction to ensure balanced enrollment of HF subjects with mild LV dysfunction (LVEF = 36%-49%) and those with preserved LVEF (≥ 50% \[i.e. heart failure with preserved ejection fraction - HFpEF\]).

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: January 31, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)