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Implantable Device

Insertable Cardiac Monitor for Atrial Fibrillation Detection in Heart Failure Patients (ASSERT-AF Trial)

N/A

Recruiting

Led By Mehmet Aktas, MD

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

LVEF > 35% on a cardiac imaging study (echocardiogram, nuclear imaging, cardiac magnetic resonance imaging) performed during the past 12 calendar months

HF exacerbation requiring treatment with intravenous decongestive therapy in a hospital setting for an acute HF event during the past 12 calendar months

Must not have

Unable or unwilling to cooperate with the protocol

Known or documented history AF or atrial flutter any time in past

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trialseeks to find out how to help people with heart failure who are at risk of stroke by using a device to monitor their heart rhythm.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include discomfort or infection at the implant site, allergic reaction to materials in the device, bleeding, bruising, and rarely more serious complications like damage to blood vessels or nerves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I was hospitalized and treated with IV fluids for heart failure in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am willing and able to follow the study's requirements.

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I have a history of atrial fibrillation or flutter.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Median Time to first detection of AF lasting > 5 minutes

Secondary study objectives

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

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

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

+3 more

Other study objectives

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.

Cardiac Arrhythmia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ASSERT insertable cardiac monitorExperimental Treatment1 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 ManagementActive Control1 Intervention

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

0 / 4Eligibility criteria met