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

February 8, 2022 updated by: Mehmet Aktas, University of Rochester

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Rochester, New York, United States, 14621
        • Rochester Regional Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 50 years at date of consent.
  • LVEF >50% as determined on imaging study measured in the last 6 calendar months prior to or on consent date.
  • Hospitalized for HF within the past 12 calendar months prior to consent date.
  • Stabilized patients defined as being off all IV therapies for at least 24 hours prior to consent date.
  • Paroxysmal AF diagnosed within the past 6 calendar months or early persistent AF, defined as an AF episode lasting greater than 7 days but less than 6 calendar months prior to consent date.
  • Indicated for oral anticoagulation according to current guidelines (CHA2DS2-VASc ≥ 2 in men or ≥ 3 in women at the time of consent)*
  • Patient with CIED in situ at time of consent or scheduled to undergo ICM implant for AF management within 2 calendar months of randomization.

Exclusion Criteria:

  • Previous catheter or surgical ablation of AF any time in the past.
  • Long-standing persistent AF (>1-year prior to consent date) or permanent AF.
  • Chronic pulmonary disease requiring home oxygen or oral/IV steroid therapy in the past 12 calendar months prior to consent date.
  • Active infection at time of consent but may be re-considered for enrollment later after effective treatment.
  • Left atrial size >50 mm as measured by echo in the past 6 calendar months prior to consent date.
  • Untreated obstructive sleep apnea any time in past.
  • Myocardial infarction in past 3 calendar months prior to consent date.
  • Coronary artery bypass graft (CABG) surgery in past 3 calendar months prior to consent date.
  • Stroke in past 3 calendar months prior to consent date.
  • Intra-cardiac thrombus precluding ability to undergo AF ablation at time of consent but may be re-considered for enrollment later after effective treatment.
  • Infiltrative cardiomyopathy (sarcoid, amyloid) any time in past.
  • Active myocarditis at time of consent but may be re-considered for enrollment later after effective treatment.
  • Hypertrophic cardiomyopathy at any time in past.
  • Known pericardial constriction.
  • Uncontrolled hypertension (SBP > 160 mmHg) at time of consent but may be re- considered for enrollment later after effective treatment.
  • Untreated hypothyroidism or hyperthyroidism but may be re-considered for enrollment later after effective treatment.
  • Pregnancy or nursing.
  • Valvular AF or presence of a prosthetic valve.
  • Undergoing dialysis or have advanced renal dysfunction (eGFR <30 ml/min/m2) defined as 3 times the upper limits of AST or ALT during the past 6 calendar months.
  • Contraindication to anticoagulation.
  • Metabolic derangements (e.g. renal/hepatic failure, electrolyte disturbance, etc.), prohibiting study (EP) study and ablation.
  • Cognitive impairment.
  • Life expectancy < 1 year following consent date.
  • Unwilling to comply with all study protocol-required testing.
  • Unwilling or unable to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Conventional Treatment
Subjects will receive management of AF consisting of either rate or rhythm control.
ACTIVE_COMPARATOR: AF Ablation
Subjects will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of healthcare utilization.
Time Frame: up to 12 months
Number of unplanned office visits, hospitalizations, and emergency room visits.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burden of Atrial Fibrillation (AF)
Time Frame: Between baseline and 12 months
Percentage of time spent in AF (i.e. amount of time spent in AF divided by the total amount of CIED monitoring time).
Between baseline and 12 months
Change in quality of life measures in Patient-Reported Outcomes Measurement Information System (PROMIS).
Time Frame: Between baseline and 6 months
Consists of 24 questions with a scale of 1-5 with 1 being the worst
Between baseline and 6 months
6-minute Walk Test
Time Frame: 6 Months
Mean changes in functional status
6 Months
Quality of life measures using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: Between baseline and 6 months
Consists of 8 questions with a scale of 1-5 with 1 being the worst
Between baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Biosense Webster, Inc.

Investigators

  • Principal Investigator: Mehmet K Aktas, MD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 25, 2021

Primary Completion (ACTUAL)

September 21, 2021

Study Completion (ACTUAL)

September 21, 2021

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (ACTUAL)

March 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00004367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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