Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation (H-FIB)
Device: Boston Scientific Vessix Renal Denervation System
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation|
- Anti-arrhythmic drug (AAD)-free single-procedure freedom from atrial fibrillation recurrence [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The change in QoL from baseline to 12 months will be measured using two quality of life instruments (AFEQT and SF-12).
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2021|
|Estimated Primary Completion Date:||September 2020 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635998
|Contact: Sam Cammack, MA, MPHfirstname.lastname@example.org|
|Contact: Betsy Ellsworth, MSNemail@example.com|
|United States, California|
|Regional Cardiology Associates||Active, not recruiting|
|Sacramento, California, United States, 95819|
|United States, Florida|
|Florida Hospital||Not yet recruiting|
|Orlando, Florida, United States, 32803|
|Contact: Leann Goodwin, RN 407-303-8059 Leann.Goodwin@FLHOSP.ORG|
|Principal Investigator: Usman Siddiqui, MD|
|United States, Kansas|
|University of Kansas Medical Center||Completed|
|Kansas City, Kansas, United States, 66160|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Grace Ha 617-643-0456 firstname.lastname@example.org|
|Principal Investigator: Moussa Mansour, MD|
|Brigham and Women's Hospital||Completed|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Mount Sinai Hospital||Recruiting|
|New York, New York, United States, 10029|
|Contact: Betsy Ellsworth, MSN, ANP 212-824-8902 email@example.com|
|Contact: Rachel Hirshorn 212-824-8909 firstname.lastname@example.org|
|Principal Investigator: Marc Miller, MD|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Debi Everidge, RN 843-792-2944 email@example.com|
|Principal Investigator: Frank Cuocco, MD|
|United States, Texas|
|Texas Cardiac||Not yet recruiting|
|Austin, Texas, United States, 78705|
|Contact: Deb Cardinal, RN 512-458-9410 firstname.lastname@example.org|
|Principal Investigator: Andrea Natale, MD|
|Na Homolce Hospital||Recruiting|
|Prague, Czech Republic, 15030|
|Contact: Stepan Kralovec 00420 777671069 email@example.com|
|Principal Investigator: Petr Neuzil, MD, PhD|
|Principal Investigator:||Vivek Reddy, MD||Icahn School of Medicine at Mount Sinai|