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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Implantable device that provides accurate daily transmission. 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™ 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.
University of Rochester Medical Center
Rochester, New York, United States
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, existing CIED, or non-invasive LT-ECG monitor 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).
Time frame: 3-15 months (12 months)
Mean Healthcare utilization
Total number of hospitalizations for any cause, ED visits, and unplanned office visits recorded at each study follow-up visit
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline to 15 months
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