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

Sponsor
University of Rochester (Other)
Overall Status
Terminated
CT.gov ID
NCT04327596
Collaborator
Biosense Webster, Inc. (Industry)
2
Enrollment
2
Locations
2
Arms
7.9
Actual Duration (Months)
1
Patient Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Subjects will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter.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
Official Title:
Randomized Clinical Trial of Radiofrequency Ablation for Atrial Fibrillation in Patients With Heart Failure With Preserved Ejection Fraction for Reduced Healthcare Utilization
Actual Study Start Date :
Jan 25, 2021
Actual Primary Completion Date :
Sep 21, 2021
Actual Study Completion Date :
Sep 21, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Rate of healthcare utilization. [up to 12 months]

    Number of unplanned office visits, hospitalizations, and emergency room visits.

Secondary Outcome Measures

  1. Burden of Atrial Fibrillation (AF) [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).

  2. Change in quality of life measures in Patient-Reported Outcomes Measurement Information System (PROMIS). [Between baseline and 6 months]

    Consists of 24 questions with a scale of 1-5 with 1 being the worst

  3. 6-minute Walk Test [6 Months]

    Mean changes in functional status

  4. Quality of life measures using the Kansas City Cardiomyopathy Questionnaire (KCCQ) [Between baseline and 6 months]

    Consists of 8 questions with a scale of 1-5 with 1 being the worst

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rochester Regional Health Rochester New York United States 14621
2 University of Rochester Medical Center Rochester New York United States 14642

Sponsors and Collaborators

  • University of Rochester
  • Biosense Webster, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mehmet Aktas, Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT04327596
Other Study ID Numbers:
  • 00004367
First Posted:
Mar 31, 2020
Last Update Posted:
Feb 23, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation

Study Results

No Results Posted as of Feb 23, 2022