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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Middelheim Hospital
Antwerp, Belgium
Ziekenhuis Oost--Limburg
Genk, Belgium
Universitatklinikum
Bonn, Germany
Acute Procedural Safety
Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge: * SAE's related to groin and vascular access complications, and * SAE's related to renal artery injury.
Time frame: One Week
Chronic Procedural Safety
Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months
Time frame: 6 months
Renal Denervation Procedure Effectiveness
Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction \> 10 mmHg at 6 months compared to baseline
Time frame: From baseline to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cardiovascular Center Sankt Katharinen
Frankfurt, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Univ. Medical Klinik III
Heidelberg, Germany
Franziskus Hospital
Münster, Germany
Hospital San Raffaele
Milan, Italy
Centre Hospitalier De Luxembourg
Luxembourg, Luxembourg
Santa Catharina Hospital
Eindhoven, Netherlands
...and 4 more locations