Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation
Completed · Not applicable
Conditions studied: Uncontrolled Hypertension, Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT01635998
- Run by
- Vivek Reddy
- People needed
- 50
- Starts
- 2012-09-17
- Expected to finish
- 2019-07-11
- Last updated by the study team
- 2020-11-05
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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:
- Inability to access renal vasculature
- Main renal arteries < 3 mm in diameter or < 20 mm in length.
- 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.
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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