Radiofrequency (RF) Ablation for Atrial Fibrillation (AF) in Patients With Heart Failure With Preserved Ejection Fraction
NCT ID: NCT04327596
Last Updated: 2022-02-23
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
2 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-01-25
Study Completion Date
2021-09-21
Brief Summary
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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.
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Detailed Description
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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
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Heart Failure With Preserved Ejection Fraction
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SINGLE_GROUP
Subjects will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Conventional Treatment
Subjects will receive management of AF consisting of either rate or rhythm control.
Group Type
NO_INTERVENTION
No interventions assigned to this group
AF Ablation
Subjects will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter
Group Type
ACTIVE_COMPARATOR
RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter
Intervention Type
PROCEDURE
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.
Interventions
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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.
Intervention Type
PROCEDURE
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Sponsor Role
collaborator
University of Rochester
OTHER
Sponsor Role
lead
Responsible Party
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Mehmet Aktas
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Mehmet K Aktas, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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Rochester Regional Health
Rochester, New York, United States
Site Status
University of Rochester Medical Center
Rochester, New York, United States
Site Status
Countries
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United States
References
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Other Identifiers
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00004367
Identifier Type: -
Identifier Source: org_study_id
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