Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation (H-FIB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01635998|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2012
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Uncontrolled Hypertension Atrial Fibrillation||Device: Boston Scientific Vessix Renal Denervation System||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation|
|Actual Study Start Date :||September 17, 2012|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: Intervention arm
These subjects will undergo routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
Device: Boston Scientific Vessix Renal Denervation System
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
No Intervention: Control arm
These subjects will undergo routine catheter ablation of atrial fibrillation only.
- Anti-arrhythmic drug (AAD)-free single-procedure freedom from atrial fibrillation recurrence [ Time Frame: up to 12 months ]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).
- AAD-free single-procedure freedom from AF recurrence through 24 months [ Time Frame: up to 24 months ]AAD-free single-procedure freedom from AF recurrence through 24 months (not-including recurrences within the first 90 days of the initial ablation procedure)
- 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 ]Freedom from AF recurrence through 24 months (not-including the pre-defined 90 day blanking period) despite taking AADs
- Blood pressure control as compared to baseline [ Time Frame: baseline, 6 months, 12 months, and 24 months ]Blood pressure control between the two groups as compared to baseline at 6 months, 12 months and 24 months.
- Major adverse cardiac events (MACE) [ Time Frame: up to 24 months ]defined as a non-weighted composite score of: death, stroke, CHF hospitalization, clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion within 12 months of randomization
- Serious Adverse Events (SAE) [ Time Frame: up to 24 months ]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
- change in measures of LV hypertrophy and LA size [ Time Frame: at baseline and at 12 months ]Differences in measures of LV hypertrophy (LV wall thickness, mitral inflow parameters) and LA size by TTE at baseline and at 12 months for each patient
- Procedure adverse events [ Time Frame: up to 24 months ]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).
- anti-hypertensive medications [ Time Frame: at 24 months ]Total number of anti-hypertensive medications at study end, compared between the two treatment arms
- change in Quality of Life [ Time Frame: baseline and 12 months ]The change in QoL from baseline to 12 months will be measured using two quality of life instruments (AFEQT and SF-12).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635998
|United States, California|
|Regional Cardiology Associates|
|Sacramento, California, United States, 95819|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Mount Sinai Hospital|
|New York, New York, United States, 10029|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|Austin, Texas, United States, 78705|
|Na Homolce Hospital|
|Prague, Czechia, 15030|
|Principal Investigator:||Vivek Reddy, MD||Icahn School of Medicine at Mount Sinai|