Native Kidney Denervation in Patients With End Stage Renal Disease

End Stage Renal Disease Clinical Trial

Official title:

Native Kidney Denervation in Patients With End Stage Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551304
• Other study ID #: TP-020 & TP-039
• Status: Completed
• Phase: Phase 1
• First received: October 26, 2007
• Last updated: November 2, 2012
• Start date: October 2007

Study information

• Verified date: November 2012
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• Ardian Catheter

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
Poland	John Paull II Hosptial	Cracow

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Countries where clinical trial is conducted

Australia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide confirmation that renal denervation in ESRD patients is safe and feasible.
Secondary	To provide evidence of denervation, indication of physiologic response, and assess device performance.