Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation

Study Overview
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Brief Summary
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To prospectively investigate the efficacy of an insertable cardiac monitor-guided atrial fibrillation (AF) management in reducing subsequent AF burden in patients with persistent or paroxysmal AF undergoing atrial catheter ablation (CA).

Detailed Description
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In this study, 120 subjects from the University of Rochester enrolling site will be randomized (1:1) to conventional AF management vs. Abbott ICM- guided AF management following ablation for persistent AF. Subjects will be followed for 15 months including a 3 month blanking period following AF ablation. The study subject population will include subjects with paroxysmal atrial fibrillation (per 2019 HRS guidelines definition: an episode of AF that terminates spontaneously or with intervention in less than seven days) or persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than 1 year), according to current guideline indications for persistent AF ablation and Abbott ICM implantation. The Abbott ICM incorporates a mobile app (myMerlin) that allows early detection of AF recurrence through patient-triggered remote transmissions and correlation with symptoms based on subclinical AF (SCAF) and patient-triggered remote transmissions. Future FDA-approved Abbott ICM devices using the same functionality may also be utilized in this study. This is a Phase 4 study, and we are comparing two management strategies that are currently employed in clinical practice.

Official Title
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Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation (ICM REDUCE-AF)

Conditions
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Atrial Fibrillation, Cardiovascular Diseases, Heart Diseases, Arrhythmias, Cardiac, Pathologic Processes

Intervention / Treatment
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* Device: Insertable Cardiac Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of paroxysmal atrial fibrillation (per 2019 HRS guidelines definition: an episode of AF that terminates spontaneously or with intervention in less than seven days), according to current guideline indications for paroxysmal AF CA (Class I/II); or patients with history of persistent atrial fibrillation (per 2019 HRS guidelines definition: sustained AF episode lasting more than 7 days, but less than 1 year), according to current guideline indications for persistent AF CA (Class I/IIIa) any time in the past. 18 years of age or older at time of consent CA to be performed for AF as standard of care within 2 calendar months after consent and prior to randomization date Abbott ICM device indicated for monitoring symptoms after CA as standard of care and inserted within 2 calendar months after consent and prior to randomization date Patients with an existing CIED (ICD/CRTD/PPM/ICM) are allowed if there is an atrial lead to track AF. Exclusion Criteria: Inability or unwilling to undergo CA (e.g., presence of intra-cardiac thrombus, contraindication to anticoagulation or other contraindication to CA) Inability or unwilling to undergo Abbott ICM device insertion Inability to tolerate any AAD therapy Permanent atrial fibrillation lasting more than 3 years prior to date of consent NYHA class IV congestive heart failure Life expectancy <1 year after consent date for any medical condition Pregnancy or nursing Unwillingness to comply with all post-procedural follow-up requirements and to sign informed consent Participation in other interventional research studies (observational registries are allowed).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study population will include 120 subjects with history of paroxysmal or persistent AF who have been referred for a CA procedure based on conventional clinical indications and who will be randomized 1:1 to conventional (control arm) or ICM-guided management (early intervention arm).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICM-guided Management<br>Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection. | Device: Insertable Cardiac Monitor<br>* Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.<br>* Other names: Confirm Rx™;|
| Placebo Comparator: Conventional Management<br>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). | Device: Insertable Cardiac Monitor<br>* Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.<br>* Other names: Confirm Rx™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean amount of time spent in AF | The primary endpoint of the trial is total AF burden between 3 and 15 months after the index CA procedure (i.e. over 1-year post-blanking), as detected by an ICM which will be inserted prior to or at the time of the CA procedure in all study subjects. AF recurrence is defined as any episode of AF lasting >30 seconds. AF burden will be defined as the mean amount of time spent in AF over the pre-specified period of time (excluding short AF episodes of ≤30 seconds). | 3-15 months (12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Healthcare utilization | Total number of hospitalizations for any cause, ED visits, and unplanned office visits recorded at each study follow-up visit | 15 months | 
| Mean change in Functional capacity as measured by Cardiopulmonary Exercise Test (CPET) | Function capacity will be reported as peak VO2, which will be determined from CPET. | Baseline to 15 months | 
| Mean change in Functional capacity as measured by ICM | The average daily count of steps derived from the inserted cardiac monitor | Baseline to 15 months | 
| Mean change in Quality of life using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire | The AFEQT questionnaire will be used to collect quality of life data. The questionnaire has 20 questions on a 7-point Likert scale that assess symptoms, daily activities and treatment concerns. Scores range from 20-140 with higher scores indicating worse outcomes. | Baseline to 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICM, Confirm Rx™ , AF Ablation, Atrial Arrhythmia