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).
Full Title of Study: “Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation (ICM REDUCE-AF)”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: September 30, 2025
In this study, 120 subjects from the University of Rochester enrolling site will be randomized (1:1) to conventional AF management vs. Abbott Confirm Rx™ 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 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 Confirm Rx™ ICM implantation. The Abbott Confirm Rx™ 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.
- Device: Insertable Cardiac Monitor
- Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
Arms, Groups and Cohorts
- Active Comparator: ICM-guided Management
- Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
- Placebo Comparator: Conventional Management
- 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).
Clinical Trial Outcome Measures
- Mean amount of time spent in AF
- Time Frame: 3-15 months (12 months)
- 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).
- Mean Healthcare utilization
- Time Frame: 15 months
- Total number of hospitalizations for any cause, ED visits, and unplanned office visits recorded at each study follow-up visit
- Mean change in Functional capacity as measured by Cardiopulmonary Exercise Test (CPET)
- Time Frame: Baseline to 15 months
- Function capacity will be reported as peak VO2, which will be determined from CPET.
- Mean change in Functional capacity as measured by ICM
- Time Frame: Baseline to 15 months
- The average daily count of steps derived from the inserted cardiac monitor
- Mean change in Quality of life using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire
- Time Frame: Baseline to 15 months
- 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.
Participating in This Clinical Trial
- 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. – 50 years of age or older at time of consent – CHA2DS2-VASc ≥ 2 in men or ≥ 3 in women at the time of consent – CA to be performed for AF for the first time as standard of care within 1 calendar month after consent and prior to randomization date – Confirm Rx™ ICM or other FDA-approved Abbott ICM device indicated for monitoring symptoms after CA as standard of care and inserted within 1 calendar month after consent and prior to randomization date 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 Confirm Rx™ ICM or other FDA-approved Abbott ICM device insertion – Inability to tolerate any AAD therapy – Sustained atrial fibrillation lasting more than 3 years prior to date of consent – Left atrial diameter of 60 mm or greater – Unsuccessful Confirm Rx™ ICM or other FDA-approved Abbott ICM device insertion – NYHA class IV congestive heart failure – Patients with an implantable cardiac rhythm device (ICD/CRTD/PPM) – LV ejection fraction ≤ 35% without a CIED, but indicated for an ICD/CRT-D – Coronary revascularization or valve surgery within 3 calendar months prior to date of consent – Prior valve surgery using a mechanical prosthesis anytime in past – 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
Gender Eligibility: All
Minimum Age: 50 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Rochester
- National Heart, Lung, and Blood Institute (NHLBI)
- Provider of Information About this Clinical Study
- Principal Investigator: Ilan Goldenberg, Professor of Medicine – University of Rochester
- Overall Official(s)
- Ilan Goldenberg, MD, Principal Investigator, University of Rochester
- Overall Contact(s)
- Ilan Goldenberg, MD, 5857335691, firstname.lastname@example.org
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