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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

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.
Select...
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:
Select...
I am willing and able to follow the study's requirements.
Select...
I have a history of atrial fibrillation or flutter.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median Time to first detection of AF lasting > 5 minutes
Secondary outcome measures
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 outcome measures
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

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.

Find a Location

Who is running the clinical trial?

AbbottIndustry Sponsor
752 Previous Clinical Trials
477,685 Total Patients Enrolled
14 Trials studying Atrial Fibrillation
4,940 Patients Enrolled for Atrial Fibrillation
University of RochesterLead Sponsor
859 Previous Clinical Trials
538,228 Total Patients Enrolled
10 Trials studying Atrial Fibrillation
4,734 Patients Enrolled for Atrial Fibrillation
Mehmet Aktas, MDPrincipal InvestigatorUniversity of Rochester
1 Previous Clinical Trials
25 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
25 Patients Enrolled for Atrial Fibrillation

Media Library

Confirm Rx Insertable Cardiac Monitor (Implantable Device) Clinical Trial Eligibility Overview. Trial Name: NCT04818645 — N/A
Atrial Fibrillation Research Study Groups: ASSERT insertable cardiac monitor, Conventional Management
Atrial Fibrillation Clinical Trial 2023: Confirm Rx Insertable Cardiac Monitor Highlights & Side Effects. Trial Name: NCT04818645 — N/A
Confirm Rx Insertable Cardiac Monitor (Implantable Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04818645 — N/A
~318 spots leftby Jul 2028
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