Clinical trial NCT01520506: Rapid Renal Sympathetic Denervation for Resistant Hypertension
Official title: Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Resistant to Conventional Therapy
Keywords: Hypertension
Kidney Diseases
Kidney Failure, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
Collaborators: name: Medtronic - MITG
name: Meditrial Europe Ltd.
First posted: 2012-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Age 18-85 years.
3. Able to provide informed consent and comply with follow-up visits.

Exclusion Criteria:

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

Primary outcomes:
measure: Acute Procedural Safety
timeFrame: One Week
Secondary outcomes:
measure: Chronic Procedural Safety
timeFrame: 6 months
measure: Renal Denervation Procedure Effectiveness
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Middelheim Hospital
city: Genk
country: Belgium
facility: Ziekenhuis Oost--Limburg
city: Bonn
country: Germany
facility: Universitatklinikum
city: Frankfurt
country: Germany
facility: Cardiovascular Center Sankt Katharinen
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Heidelberg
country: Germany
facility: Univ. Medical Klinik III
city: Münster
country: Germany
facility: Franziskus Hospital
city: Milano
country: Italy
facility: Hospital San Raffaele
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier De Luxembourg
city: Eindhoven
country: Netherlands
facility: Santa Catharina Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC Thoraxcenter
city: Utrecht
country: Netherlands
facility: UMC Universitair Medisch Centrum
city: Auckland
country: New Zealand
facility: Mercy Angiography Unit
Study officials:
affiliation: Department of Cardiology, Catherina Hospital, Eindhoven, The Netherlands
name: W.A.L. Tonino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Interventional Cardiology, Middelheim Hospital, Antwerp, Belgium
name: Stefan Verheye, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verheye S, Ormiston J, Bergmann MW, Sievert H, Schwindt A, Werner N, Vogel B, Colombo A. Twelve-month results of the rapid renal sympathetic denervation for resistant hypertension using the OneShotTM ablation system (RAPID) study. EuroIntervention. 2015 Feb;10(10):1221-9. doi: 10.4244/EIJY14M12_02.