Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation (H-FIB)

Vivek Reddy

Status: Completed

Conditions: Atrial Fibrillation; Uncontrolled Hypertension

Treatments: Device: Boston Scientific Vessix Renal Denervation System

Study type: Interventional

Funder types: Other

Identifiers

NCT01635998

GCO 12-1465

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Intervention arm

Experimental group

Description:

These subjects will undergo routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.

Treatment:

Device: Boston Scientific Vessix Renal Denervation System

Control arm

No Intervention group

Description:

These subjects will undergo routine catheter ablation of atrial fibrillation only.