The purpose of this study is to determine if patients who receive an early radiofrequency ablation will have fewer hospitalizations, unplanned office visits, and emergency room visits than those patients treated with medical therapy alone.
In this study, subjects with HFpEF and new onset paroxysmal or persistent AF (diagnosed in the past 6 months) will be randomized in a 1:1 ratio to either intervention or medical therapy alone. Twenty subjects will be enrolled to each group for a total of 40 subjects across all enrolling sites. Subjects randomized to the intervention Group will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter. The medical therapy alone cohort will receive management of AF consisting of either rate or rhythm control. All patients will be implanted with an implantable cardiac monitor (ICM) as standard of care for AF management in heart failure except for those who already have in place an existing cardiac implantable electronic device (CIED) such as pacemaker, ICM, or implantable cardiac defibrillator (ICD). The ICM procedure will occur within 2 calendar months of randomization for both study groups (intervention or control). For the intervention arm, the CIED procedure will occur prior to or at the time of the AF ablation procedure. Subjects will be followed for 1 year with in-clinic visits occurring at 3, 6, and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Ablation of AF is standard of care in the management of patients with paroxysmal or persistent AF. The most common triggers initiating AF arise from pulmonary veins (PV) and successful electrical isolation of PV's can significantly reduce the burden of AF. Therefore, the main objective in patients undergoing ablation of AF is to achieve PV isolation.
Rochester Regional Health
Rochester, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Rate of healthcare utilization.
Number of unplanned office visits, hospitalizations, and emergency room visits.
Time frame: up to 12 months
Burden of Atrial Fibrillation (AF)
Percentage of time spent in AF (i.e. amount of time spent in AF divided by the total amount of CIED monitoring time).
Time frame: Between baseline and 12 months
Change in quality of life measures in Patient-Reported Outcomes Measurement Information System (PROMIS).
Consists of 24 questions with a scale of 1-5 with 1 being the worst
Time frame: Between baseline and 6 months
6-minute Walk Test
Mean changes in functional status
Time frame: 6 Months
Quality of life measures using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Consists of 8 questions with a scale of 1-5 with 1 being the worst
Time frame: Between baseline and 6 months
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