The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.
The purpose of this study is to examine the potential additional benefit of performing renal sympathetic denervation at the same time as an AF ablation procedure, in order to improve the long-term success of the AF procedure. To take part in this study, you must meet all study requirements. Screening visit tests and procedures such as a physical exam, blood pressure, review of medical history, blood sample, and a Transthoracic Echocardiogram (TTE) are done to see if you are eligible to be in the study. Patients who qualify for the study and provide consent will undergo catheter ablation for AF. Very thin electrode catheters, similar to long wires, will be inserted into blood vessels in the groin. Using the ablation catheter, we will "ablate" or damage the tissue adjacent to your pulmonary veins that is not behaving normally. Immediately following the catheter ablation, patients will undergo a renal angiogram in order to assess suitability for catheter-based renal sympathetic denervation. A renal angiogram is an x-ray study of the blood vessels in the kidney to evaluate for blockage, and abnormalities that could be affecting the blood supply to the kidney. It is performed by injecting contrast dye through a catheter (a tiny tube) into the blood vessels of the kidney.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation. Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
Regional Cardiology Associates
Sacramento, California, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence
The primary endpoint of this study is anti-arrhythmic drug (AAD)-free single-procedure freedom from AF recurrence through 12 months (not including a 90 day blanking period).
Time frame: up to 12 months
AAD-free Single-procedure Freedom From AF Recurrence
AAD-free single-procedure freedom from AF recurrence through 24 months (not-including recurrences within the first 90 days of the initial ablation procedure)
Time frame: up to 24 months
Freedom From AF Recurrence Despite Taking AADs
Freedom from AF recurrence through 24 months (not-including the pre-defined 90 day blanking period) despite taking AADs
Time frame: up to 24 months
Blood Pressure Control as Compared to Baseline
Blood pressure control between the two groups as compared to baseline at 6 months, 12 months and 24 months.
Time frame: baseline, 6 months, 12 months, and 24 months
Number of Participants With Major Adverse Cardiac Events (MACE)
Number of Participants with Major adverse cardiac events (MACE) defined as a non-weighted composite score of: death, stroke, CHF hospitalization, and clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion within 12 months of randomization
Time frame: within 12 months of randomization
Number of Participants With Serious Adverse Events (SAE)
SAE-any experience that results in a fatality or is life threatening; results in significant or persistent disability; requires or prolongs hospitalization; results in congenital anomaly/birth defect; or represents other significant hazards or potentially serious harm to research subjects or others, in the opinion of the investigators. Important medical events that may not result in above may be considered a SAE when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition
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Mount Sinai Hospital
New York, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Na Homolce Hospital
Prague, Czechia
Siberian Biomedical Research Center Ministry of Health Russian Federation
Novosibirsk, Russia
Time frame: up to 24 months
Left Atrial (LA) Size
LA size by TTE at baseline and at 12 months
Time frame: at baseline and at 12 months
Ejection Fraction (EF)
Ejection fraction (EF) is a measurement, expressed as a percentage, of how much blood the left ventricle pumps out with each contraction. A normal heart's ejection fraction may be between 50 and 70 percent.
Time frame: at baseline and at 12 months
Number of Participants With Procedure Adverse Events
Causality will be defined as adverse events that, after careful medical evaluation, are considered with a high degree of certainty to be related to the intervention (AF ablation ± renal sympathetic denervation).
Time frame: up to 24 months
Number of Anti-hypertensive Medications
Total number of anti-hypertensive medications at study end, compared between the two treatment arms
Time frame: baseline and 24 months
Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT)
The change in quality of life (QoL) from baseline to 12 months as measured by AFEQT, a 20- item instrument. Full range from 0 to 100, with higher score indicates higher level of QoL.
Time frame: baseline, 12 months and 24 months