Rapid Renal Sympathetic Denervation for Resistant Hypertension

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Systolic blood pressure ≥ 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications that includes a diuretic and that has been stable for 2 weeks prior to screening.
Age 18-85 years.
Able to provide informed consent and comply with follow-up visits.

Exclusion Criteria

Diameter of left or right renal artery less than 4 mm or greater than 7mm.
Length of target segment of left or right renal artery less than 20mm.
Other renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty.
End-stage renal disease requiring dialysis or renal transplant.
estimated Glomerular Filtration Rate < 45 mL/min per 1.73 m2.
Type 1 diabetes mellitus.
Myocardial infarction, unstable angina, or cerebrovascular events within 6 months prior to screening.
Severe valvular heart disease for which reduction of blood pressure would be considered hazardous.
Bleeding disorder or refusing blood transfusions.
Pregnancy or breast feeding.
Peripheral vascular disease precluding catheter insertion.
Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety or effectiveness of the participant or the study.
Current enrollment in another investigational drug or device Study.

Arm && Interventions

Group	Intervention	Description
Rapid Renal Denervation	Covidien OneShot™ System	-

Primary Outcome Measures

Name	Time	Method
Acute Procedural Safety	One Week	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.

Secondary Outcome Measures

Name	Time	Method
Chronic Procedural Safety	6 months	Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months
Renal Denervation Procedure Effectiveness	From baseline to 6 months	Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction \> 10 mmHg at 6 months compared to baseline

Locations (14): Universitatklinikum
🇩🇪
Bonn, Germany
Asklepios Klinik St. Georg
🇩🇪
Hamburg, Germany
Cardiovascular Center Sankt Katharinen
🇩🇪
Frankfurt, Germany
Univ. Medical Klinik III
🇩🇪
Heidelberg, Germany
St. Antonius Ziekenhuis
🇳🇱
Nieuwegein, Netherlands
Mercy Angiography Unit
🇳🇿
Auckland, New Zealand
Ziekenhuis Oost--Limburg
🇧🇪
Genk, Belgium
Erasmus MC Thoraxcenter
🇳🇱
Rotterdam, Netherlands
UMC Universitair Medisch Centrum
🇳🇱
Utrecht, Netherlands
Middelheim Hospital
🇧🇪
Antwerp, Belgium
Santa Catharina Hospital
🇳🇱
Eindhoven, Netherlands
Hospital San Raffaele
🇮🇹
Milano, Italy
Centre Hospitalier De Luxembourg
🇱🇺
Luxembourg, Luxembourg
Franziskus Hospital
🇩🇪
Münster, Germany