Renal Denervation in Patients With Refractory Hypertension

Medtronic

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Device: Ardian Symplicity™ Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00483808

TP-015 & TP-038

Details and patient eligibility

About

To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >= 18 years of age.
• a systolic blood pressure of 160 mmHg or greater.
• receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening.
• agrees to have the study procedure(s) performed and additional procedures and evaluations, including repeat phlebotomy, imaging, urine analyses, and clinical examination.
• competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion criteria

• renal arterial abnormalities
• end stage renal disease requiring dialysis or renal transplant
• serum Cr > 3, or calculated GFR < 45 ml/min
• has experienced MI, unstable angina pectoris, or CVA with 6 months
• others

Trial design

73 participants in 1 patient group

Denervation

Experimental group

Description:

Renal denervation using the Symplicty Catheter

Treatment:

Device: Ardian Symplicity™ Catheter