NCT04327596

Radiofrequency (RF) Ablation for Atrial Fibrillation (AF) in Patients With Heart Failure With Preserved Ejection Fraction

Randomized Clinical Trial of Radiofrequency Ablation for Atrial Fibrillation in Patients With Heart Failure With Preserved Ejection Fraction for Reduced Healthcare Utilization

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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. 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.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
PROCEDURE	RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter	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.

Timeline

• Start date: 2021-01-25
• Primary completion: 2021-09-21
• Completion: 2021-09-21
• First posted: 2020-03-31
• Last updated: 2022-02-23

Locations

2 sites across 1 country: United States