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Device

Insertable Cardiac Monitor for Atrial Fibrillation (ICMREDUCE-AF Trial)

N/A

Recruiting

Led By Ilan Goldenberg, 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

18 years of age or older at time of consent

Be older than 18 years old

Must not have

Inability to tolerate any AAD therapy

NYHA class IV congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-15 months (12 months)

Summary

This trial will investigate whether using a device to monitor heart activity can reduce the amount of time a patient with AF spends in AF after having a catheter ablation.

Who is the study for?

This trial is for adults with a history of paroxysmal or persistent atrial fibrillation who are undergoing their first catheter ablation. They must have a certain risk score for stroke (CHA2DS2-VASc ≥ 2 in men, ≥ 3 in women), and be able to receive an insertable cardiac monitor. People with severe heart failure, life expectancy less than a year, large left atrium, recent major heart surgery, mechanical valve prosthesis, or those unable to undergo the procedure are excluded.

What is being tested?

The study tests if using an insertable cardiac monitor can help manage atrial fibrillation more effectively after catheter ablation. Participants will be monitored to see if this approach reduces the frequency and severity of AF episodes compared to standard care without continuous monitoring.

What are the potential side effects?

Potential side effects from the insertable cardiac monitor may include discomfort at the insertion site, infection risk, allergic reaction to device materials, and possible interference with other devices or medical procedures.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

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

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I cannot tolerate antiarrhythmic drug therapy.

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I have severe heart failure.

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I cannot or do not want to undergo CA.

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I have had atrial fibrillation for over 3 years.

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I cannot or do not want to have an Abbott ICM device inserted.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-15 months (12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-15 months (12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-15 months (12 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

Mean amount of time spent in AF

Secondary study objectives

Mean Healthcare utilization

Mean change in Functional capacity as measured by Cardiopulmonary Exercise Test (CPET)

Mean change in Functional capacity as measured by ICM

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ICM/CIED/non-invasive LT-ECG patch arrhythmia detection guided ManagementActive Control1 Intervention

Implantable device (ICM/CIED) that provides accurate daily transmission of cardiac electrical data for arrhythmia detection. Patients without an existing CIED who prefer to use noninvasive LT-ECG monitoring will be offered to use the Carnation Ambulatory Monitor ("CAM™"; Bardy Diagnostics). The CAM™ is patch approved for LT-ECG monitoring applied to the skin over the chest for a time-period of 7-days every 2 months for cardiac electrical data for arrhythmia detection.

Group II: Conventional ManagementPlacebo Group1 Intervention

Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).

0 / 6Eligibility criteria met