Clinical trial NCT04327596: Radiofrequency (RF) Ablation for Atrial Fibrillation (AF) in Patients With Heart Failure With Preserved Ejection Fraction
Official title: Randomized Clinical Trial of Radiofrequency Ablation for Atrial Fibrillation in Patients With Heart Failure With Preserved Ejection Fraction for Reduced Healthcare Utilization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2020-03-31
Enrollment: 2
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of healthcare utilization.
timeFrame: up to 12 months
Secondary outcomes:
measure: Burden of Atrial Fibrillation (AF)
timeFrame: Between baseline and 12 months
measure: Change in quality of life measures in Patient-Reported Outcomes Measurement Information System (PROMIS).
timeFrame: Between baseline and 6 months
measure: 6-minute Walk Test
timeFrame: 6 Months
measure: Quality of life measures using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Between baseline and 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Rochester Regional Health
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Mehmet K Aktas, MD
role: PRINCIPAL_INVESTIGATOR
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