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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01635998
Recruitment Status : Recruiting
First Posted : July 10, 2012
Last Update Posted : July 2, 2017
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Uncontrolled Hypertension Atrial Fibrillation Device: Boston Scientific Vessix Renal Denervation System Not Applicable

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2012
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Other Names:
  • renal denervation
  • denervation
No Intervention: Control arm
These subjects will undergo routine catheter ablation of atrial fibrillation only.

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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).

  8. anti-hypertensive medications [ Time Frame: at 24 months ]
    Total number of anti-hypertensive medications at study end, compared between the two treatment arms

  9. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Inclusion Criteria
  • Age ≥ 18 years of age
  • History of AF (paroxysmal or persistent) and planned for a guideline-supported catheter ablation procedure
  • History of significant hypertension (defined as SBP ≥160 mm Hg and/or DBP ≥100 mmHg) and receiving treatment with at least one anti-hypertensive medication OR Clinical History of hypertension and receiving treatment with at least two anti-hypertensive medications (specifically for blood pressure reduction).
  • Renal vasculature is accessible as determined by intra-procedural renal angiography.
  • Ability to understand the requirements of the study
  • Willingness to adhere to study restrictions, comply with all post-procedural follow-up requirements and to sign informed consent

Exclusion Criteria

  • Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
  • Prior left atrial ablation for an atrial arrhythmia (before this index procedure)
  • Patients with NYHA class IV congestive heart failure
  • Individual has known secondary hypertension
  • Individual has renal artery anatomy that is ineligible for treatment including:

    1. Inability to access renal vasculature
    2. Main renal arteries < 3 mm in diameter or < 20 mm in length.
    3. Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets standards for surgical repair or interventional dilation.
    4. A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment.
  • Individual has an estimated glomerular filtration rate (eGFR) of less than 45mL/min/1.73m2, using the MDRD calculation.
  • Individual has a single functioning kidney (either congenitally or iatrogenically).
  • Individual is pregnant or nursing.
  • Life expectancy <1 year for any medical condition

Information from the National Library of Medicine

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 identifier (NCT number): NCT01635998

Contact: Sam Cammack, MA, MPH 212-824-8931
Contact: Betsy Ellsworth, MSN 212-824-8902

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   
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   
Contact: Rachel Hirshorn    212-824-8909   
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   
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   
Principal Investigator: Andrea Natale, MD         
Na Homolce Hospital Recruiting
Prague, Czechia, 15030
Contact: Stepan Kralovec    00420 777671069   
Principal Investigator: Petr Neuzil, MD, PhD         
Sponsors and Collaborators
Vivek Reddy
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Icahn School of Medicine at Mount Sinai Identifier: NCT01635998     History of Changes
Other Study ID Numbers: GCO 12-1465
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
renal sympathetic denervation
renal catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes