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Device
Insertable Cardiac Monitor for Atrial Fibrillation (ICMREDUCE-AF Trial)
Phase 4
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-15 months (12 months)
Awards & highlights
ICMREDUCE-AF Trial 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.Check my eligibility
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.See study design
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.
ICMREDUCE-AF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
ICMREDUCE-AF Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean amount of time spent in AF
Secondary outcome measures
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 moreICMREDUCE-AF Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ICM-guided ManagementActive Control1 Intervention
Implantable device that provides accurate daily transmission of 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).
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Who is running the clinical trial?
University of RochesterLead Sponsor
837 Previous Clinical Trials
517,997 Total Patients Enrolled
10 Trials studying Atrial Fibrillation
5,091 Patients Enrolled for Atrial Fibrillation
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,310,992 Total Patients Enrolled
45 Trials studying Atrial Fibrillation
539,473 Patients Enrolled for Atrial Fibrillation
Ilan Goldenberg, MDPrincipal InvestigatorUniversity of Rochester
2 Previous Clinical Trials
1,098 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
477 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will get an Abbott ICM device for symptom monitoring after cardiac ablation within 2 months of giving consent.I cannot tolerate antiarrhythmic drug therapy.I am 18 years old or older.I have severe heart failure.I cannot or do not want to undergo CA.I have had atrial fibrillation for over 3 years.I cannot or do not want to have an Abbott ICM device inserted.
Research Study Groups:
This trial has the following groups:- Group 1: ICM-guided Management
- Group 2: Conventional Management
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many total participants are currently enrolled in the research project?
"Affirmative, data located on clinicaltrials.gov confirms that this medical investigation is currently recruiting subjects, having first been published on February 28th 2022 and most recently updated March 17th 2022. Aspiring participants will be sourced from a single site with a target enrollment of 120 patients."
Answered by AI
Are there any opportunities for participants in this experiment currently?
"The clinical trial is currently in the process of enrolment, as indicated by its listing on clinicaltrials.gov. This medical endeavour was initially posted on February 28th 2022 and has received an update as recent as March 17th 2022."
Answered by AI
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