NCT01520506

Rapid Renal Sympathetic Denervation for Resistant Hypertension

Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.

Detailed description

Unique to the OneShot™ ablation system is the ability to deliver the desired helical treatment pattern for optimal Renal Denervation (RDN) with a single balloon based-treatment, eliminating user variance inherent in the currently available point-by-point approach. In addition, technological improvements have been incorporated. The OneShot™ RF generator has a touchscreen, user friendly interface; catheter advancement is made safer with the use of a guidewire; two radiopaque markers on the catheter enable more precise device positioning; and the irrigated catheter tip reduces the risk of overheating and clot formation during RF delivery. By offering a more reliable single treatment approach, coupled with enhanced ease-of use and reduced procedure times, this technology has the potential to significantly expand clinical adoption of catheter-based renal sympathetic denervation.

Conditions

• Hypertension, Resistant to Conventional Therapy

Interventions

Type	Name	Description
DEVICE	Covidien OneShot™ System	Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-11-01
• Completion: 2014-06-01
• First posted: 2012-01-30
• Last updated: 2019-03-01
• Results posted: 2015-09-16

Locations

14 sites across 6 countries: Belgium, Germany, Italy, Luxembourg, Netherlands, New Zealand