CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 96 enrolled
Drug / intervention
Biosense Webster Celcius Thermacool catheterdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01628172
NCT01628172N/ACompleted

Renal Sympathetic Denervation for the Management of Chronic Hypertension

Vivek Reddy·interventional·Posted Jun 26, 2012·Updated Jun 29, 2016

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 26, 2012
Enrollment StartJan 1, 2011
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.0 years ago

Interventions

Biosense Webster Celcius Thermacool catheterdevice

catheter-based sympathetic renal denervation