Rapid Renal Sympathetic Denervation for Resistant Hypertension (RAPID)

Medtronic

Status: Completed

Conditions: Hypertension, Resistant to Conventional Therapy

Treatments: Device: Covidien OneShot™ System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01520506

CIP 012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Rapid Renal Denervation

Experimental group

Treatment:

Device: Covidien OneShot™ System