Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation

Status:Active, not recruiting
Conditions:Atrial Fibrillation, High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - 85
Start Date:September 17, 2012
End Date:September 2021

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Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation

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

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.

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
We found this trial at
185 Cambridge Street
Boston, Massachusetts 02114
Principal Investigator: Moussa Mansour, MD
Phone: 617-643-0456
Boston, MA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
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171 Ashley Avenue
Charleston, South Carolina 29425
Principal Investigator: Frank Cuocco, MD
Phone: 843-792-2944
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
Charleston, SC
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
Kansas City, KS
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New York, New York 10029
Principal Investigator: Marc Miller, MD
Phone: 212-824-8902
New York, NY
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Prague, 15630
Principal Investigator: Petr Neuzil, MD, PhD
Phone: 00420 777671069
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Sacramento, California 95819
Sacramento, CA
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