Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation
NCT ID: NCT01635998
Last Updated: 2020-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2012-09-17
2019-07-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention arm
These subjects will undergo routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
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
Control arm
These subjects will undergo routine catheter ablation of atrial fibrillation only.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Vivek Reddy
OTHER
Responsible Party
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Vivek Reddy
Director Cardiac Arrhythmia Service, Professor of Medicine
Principal Investigators
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Vivek Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Regional Cardiology Associates
Sacramento, California, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mount Sinai Hospital
New York, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Na Homolce Hospital
Prague, , Czechia
Siberian Biomedical Research Center Ministry of Health Russian Federation
Novosibirsk, , Russia
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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GCO 12-1465
Identifier Type: -
Identifier Source: secondary_id
GCO 12-1465
Identifier Type: -
Identifier Source: org_study_id