Rapid Renal Sympathetic Denervation for Resistant Hypertension

NCT ID: NCT01520506

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-06-30

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.

Conditions

Hypertension, Resistant to Conventional Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rapid Renal Denervation

Group Type: EXPERIMENTAL

Covidien OneShot™ System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Covidien OneShot™ Renal Denervation System

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

Meditrial Europe Ltd.

INDUSTRY

Sponsor Role: collaborator

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

W.A.L. Tonino, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Catherina Hospital, Eindhoven, The Netherlands

Stefan Verheye, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Interventional Cardiology, Middelheim Hospital, Antwerp, Belgium

Locations

Middelheim Hospital

Antwerp, , Belgium

Ziekenhuis Oost--Limburg

Genk, , Belgium

Universitatklinikum

Bonn, , Germany

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

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Erasmus MC Thoraxcenter

Rotterdam, , Netherlands

UMC Universitair Medisch Centrum

Utrecht, , Netherlands

Mercy Angiography Unit

Auckland, , New Zealand

Countries

Belgium; Germany; Italy; Luxembourg; Netherlands; New Zealand

References

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.

Reference Type: DERIVED

PMID: 25452198 (View on PubMed)

Related Links

http://www.covidien.com

Covidien (manufacturer)

Other Identifiers

CIP 012

Identifier Type: -

Identifier Source: org_study_id