Native Kidney Denervation in Patients With End Stage Renal Disease

November 2, 2012 updated by: Medtronic Vascular
To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Poland
      • Cracow, Poland
        • John Paull II Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Vascular

Investigators

  • Principal Investigator: Markus Schlaich, MD, The Alfred

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Registration Dates

First Submitted

October 26, 2007

First Submitted That Met QC Criteria

October 26, 2007

First Posted (Estimate)

October 30, 2007

Study Record Updates

Last Update Posted (Estimate)

November 6, 2012

Last Update Submitted That Met QC Criteria

November 2, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-020 & TP-039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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