Rapid Renal Sympathetic Denervation for Resistant Hypertension

Hypertension, Resistant to Conventional Therapy Clinical Trial

— RAPID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520506
• Other study ID #: CIP 012
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: June 2014

Study information

• Verified date: February 2019
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Vasospasm
• Hypertension
• Hypertension, Resistant to Conventional Therapy

Intervention

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.

Locations

Country	Name	City	State
Belgium	Middelheim Hospital	Antwerp
Belgium	Ziekenhuis Oost--Limburg	Genk
Germany	Universitatklinikum	Bonn
Germany	Cardiovascular Center Sankt Katharinen	Frankfurt
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Univ. Medical Klinik III	Heidelberg
Germany	Franziskus Hospital	Münster
Italy	Hospital San Raffaele	Milano
Luxembourg	Centre Hospitalier De Luxembourg	Luxembourg
Netherlands	Santa Catharina Hospital	Eindhoven
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Erasmus MC Thoraxcenter	Rotterdam
Netherlands	UMC Universitair Medisch Centrum	Utrecht
New Zealand	Mercy Angiography Unit	Auckland

Sponsors (3)

Lead Sponsor	Collaborator
Medtronic Endovascular	Meditrial Europe Ltd., Medtronic - MITG

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Luxembourg,  Netherlands,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One Week
Secondary	Chronic Procedural Safety	Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months	6 months
Secondary	Renal Denervation Procedure Effectiveness	Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction > 10 mmHg at 6 months compared to baseline	From baseline to 6 months

External Links

•   Covidien (manufacturer)
•   Meditrial Europe Ltd CRO