Native Kidney Denervation in Patients With End Stage Renal Disease

Medtronic

Status and phase: Completed; Phase 1

Conditions: End Stage Renal Disease

Treatments: Device: Ardian Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00551304

TP-020 & TP-039

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)