Radiofrequency (RF) Ablation for Atrial Fibrillation (AF) in Patients With Heart Failure With Preserved Ejection Fraction
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Subjects will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
Description
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. Subje...
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.
Tracking Information
- NCT #
- NCT04327596
- Collaborators
- Biosense Webster, Inc.
- Investigators
- Principal Investigator: Mehmet K Aktas, MD University of Rochester