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Native Kidney Denervation in Patients With End Stage Renal Disease

Primary Purpose

End Stage Renal Disease

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Ardian Catheter

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The Alfred Hospital
John Paull II Hosptial

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00551304

First Posted

October 26, 2007

Last Updated

November 2, 2012

Sponsor

Medtronic Vascular

1. Study Identification

Unique Protocol Identification Number

NCT00551304

Brief Title

Native Kidney Denervation in Patients With End Stage Renal Disease

Official Title

Native Kidney Denervation in Patients With End Stage Renal Disease

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medtronic Vascular

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Ardian Catheter

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Markus Schlaich, MD

Organizational Affiliation

The Alfred

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Alfred Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

John Paull II Hosptial

City

Cracow

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

22457244

Citation

Schlaich MP, Hering D, Sobotka PA, Krum H, Esler MD. Renal denervation in human hypertension: mechanisms, current findings, and future prospects. Curr Hypertens Rep. 2012 Jun;14(3):247-53. doi: 10.1007/s11906-012-0264-9.

Results Reference

derived

PubMed Identifier

21714604

Citation

Hering D, Esler MD, Krum H, Mahfoud F, Bohm M, Sobotka PA, Schlaich MP. Recent advances in the treatment of hypertension. Expert Rev Cardiovasc Ther. 2011 Jun;9(6):729-44. doi: 10.1586/erc.11.71.

Results Reference

derived

PubMed Identifier

19822798

Citation

Schlaich MP, Sobotka PA, Krum H, Whitbourn R, Walton A, Esler MD. Renal denervation as a therapeutic approach for hypertension: novel implications for an old concept. Hypertension. 2009 Dec;54(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.109.138610. Epub 2009 Oct 12. No abstract available.

Results Reference

derived

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Native Kidney Denervation in Patients With End Stage Renal Disease

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