Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation

Last updated: October 15, 2020
Sponsor: Vivek Reddy
Overall Status: Completed

Phase

N/A

Condition

Atrial Fibrillation

Chest Pain

Stress

Treatment

N/A

Clinical Study ID

NCT01635998
GCO 12-1465
GCO 12-1465
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 50
Study Start date:
September 17, 2012
Estimated Completion Date:
July 11, 2019

Study 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.

Connect with a study center

  • Na Homolce Hospital

    Prague, 15030
    Czechia

    Site Not Available

  • Hôpital Cardiologique du Haut-Lévêque - Bordeaux

    Bordeaux Pessac, 33604
    France

    Site Not Available

  • Asklepios Klinik St Georg - Hamburg

    Hamburg,
    Germany

    Site Not Available

  • University of Leipzig - Heart Center

    Leipzig,
    Germany

    Site Not Available

  • Siberian Biomedical Research Center Ministry of Health Russian Federation

    Novosibirsk, 630055
    Russian Federation

    Site Not Available

  • University of Alabama - Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Regional Cardiology Associates

    Sacramento, California 95819
    United States

    Site Not Available

  • Florida Hospital

    Orlando, Florida 32803
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Texas Cardiac

    Austin, Texas 78705
    United States

    Site Not Available

  • HeartPlace Baylor

    Dallas, Texas 75204
    United States

    Site Not Available

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