Native Kidney Denervation in Patients With End Stage Renal Disease

Phase 1

Completed

• Conditions: End Stage Renal Disease

• Registration Number: NCT00551304
• Lead Sponsor: Medtronic Vascular

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-26
• Study First Submitted QC: 2007-10-26
• Study First Posted: 2007-10-30
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-02
• Last Update Posted: 2012-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

John Paull II Hosptial; 🇵🇱 Cracow, Poland

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia