The objective of this 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.
The details
Atrial fibrillation is the most common sustained cardiac arrhythmia (irregular or abnormal rhythm of the heart), occurring more frequently in those with underlying hypertension (high blood pressure). In AF, the normal regular rhythmic activity of the upper chambers or atria is replaced by chaotic irregular activity. Catheter ablation for AF is a minimally invasive procedure that can relieve symptoms and improve quality of life. Thin flexible wires called catheters are inserted into a vein and threaded up to the heart, emitting radio waves that destroy the heart tissue causing the atrial fibrillation.
People with hypertension typically have overactive renal (kidney) nerves, serving to raise blood pressure and contribute to nerve, organ and vessel damage. Renal sympathetic denervation is a technique that strips the vessels near the kidneys of nerve endings, selectively calming overactive sympathetic nerves (thereby lowering blood pressure). This trial evaluates the addition of renal sympathetic denervation to the AF-ablation procedure.
Who are they looking for?
This study will enrol 300 patients. Patients must be above 18 years of age and have a history of significant hypertension (systolic blood pressure of greater that 130 mmHg and/or diastolic blood pressure greater than 80 mmHg). Patients must have a history of paroxysmal atrial fibrillation (an episode of uncoordinated movement of the atria that occurs occasionally then stops) and plans to undergo a catheter ablation procedure.
Patients with prior left atrial ablation, congestive heart failure or low renal function (as defined by a glomerular filtration rate of less than 45 mL/min/1.73m2) will be excluded.
How will it work
Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation. The main outcome to be measured is freedom from AF recurrence without the use of anti-arrhythmic drugs (trugs taken to stop arrhythmias).
