Clinical trial NCT01635998: Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation
Official title: Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncontrolled Hypertension
Atrial Fibrillation
Keywords: renal sympathetic denervation
renal catheter ablation
hypertension
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence
timeFrame: up to 12 months
Secondary outcomes:
measure: AAD-free Single-procedure Freedom From AF Recurrence
timeFrame: up to 24 months
measure: Freedom From AF Recurrence Despite Taking AADs
timeFrame: up to 24 months
measure: Blood Pressure Control as Compared to Baseline
timeFrame: baseline, 6 months, 12 months, and 24 months
measure: Number of Participants With Major Adverse Cardiac Events (MACE)
timeFrame: within 12 months of randomization
measure: Number of Participants With Serious Adverse Events (SAE)
timeFrame: up to 24 months
measure: Left Atrial (LA) Size
timeFrame: at baseline and at 12 months
measure: Ejection Fraction (EF)
timeFrame: at baseline and at 12 months
measure: Number of Participants With Procedure Adverse Events
timeFrame: up to 24 months
measure: Number of Anti-hypertensive Medications
timeFrame: baseline and 24 months
measure: Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT)
timeFrame: baseline, 12 months and 24 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Novosibirsk
country: Russian Federation
facility: Siberian Biomedical Research Center Ministry of Health Russian Federation
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: