Status:
TERMINATED
Radiofrequency (RF) Ablation for Atrial Fibrillation (AF) in Patients With Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Biosense Webster, Inc.
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
50+ years
Phase:
NA
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 patie...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04327596
Start Date
January 25 2021
End Date
September 21 2021
Last Update
February 23 2022
Active Locations (2)
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1
Rochester Regional Health
Rochester, New York, United States, 14621
2
University of Rochester Medical Center
Rochester, New York, United States, 14642