At a glance
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Renal Sympathetic Denervation for the Management of Chronic Hypertension
In Brief
A clinical study evaluating Biosense Webster Celcius Thermacool catheter for Uncontrolled Hypertension. Completed, enrolled 96 participants across 2 sites.
Detailed Summary
Despite the development of numerous drug therapies designed to treat hypertension, it remains a considerable and poorly managed health, social and economic burden. For various reasons, including the significant health care costs of treatment, there are estimates that up to 65% of hypertensive patients have untreated and/or uncontrolled blood pressure (BP). Aside from its impact on renal function, chronic hypertension significantly increases the risk for stroke, coronary artery disease, heart failure, and vascular disease. It is believed to be involved in the progression of cardiac arrhythmias. This link between hypertension and cardiovascular health has been well described; as has their combined effect on the aging and obesity-battling Western world. The recently published results of the Symplicity HTN-2 trial (Renal sympathetic denervation in patients with treatment resistant hypertension) establishing the therapeutic benefit of catheter-based renal sympathetic denervation for hypertension, have enormous potential for the management of a large and challenging patient population. The proposed, multicenter trial will attempt to confirm and expand on this promising data by conducting a double-blinded, placebo-controlled trial. Patients may qualify to participate in this research study if their doctor has determined that they have drug-resistant, chronic hypertension. Overall participation in this research study should be about 13 months which includes about 1 month to start the study procedure and 12 months of follow-up after the study procedure.
Study Details
Timeline
Interventions
catheter-based sympathetic renal denervation