Native Kidney Denervation in Patients With End Stage Renal Disease

Phase 1CompletedNCT00551304

Medtronic Vascular

Overview

To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

End Stage Renal Disease

Interventions

Ardian CatheterDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult \>= 18 years of age * end stage renal disease, undergoing concurrent dialysis treatment * poorly controlled blood pressure on at least 2 antihypertensive drugs * agrees to have the study procedure(s) performed and additional procedures and evaluations, including interventions and follow up visits * competent and willing to provide written, informed consent to participate in this clinical study. Exclusion Criteria: * renal arterial abnormalities * myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six (6) months * hemodynamically significant valvular heart disease * implantable cardioverter defibrillator (ICD) or pacemaker * respiratory support. * pregnant, nursing or planning to be pregnant * other

Locations (2)

The Alfred Hospital

Melbourne, Victoria, Australia

John Paull II Hosptial

Cracow, Poland

Outcomes

Primary Outcomes

To provide confirmation that renal denervation in ESRD patients is safe and feasible.

Secondary Outcomes

To provide evidence of denervation, indication of physiologic response, and assess device performance.

Data from ClinicalTrials.gov

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