Native Kidney Denervation in Patients With End Stage Renal Disease

This study has been completed.

Sponsor:

Information provided by:

Medtronic Vascular

ClinicalTrials.gov Identifier:

NCT00551304

First received: October 26, 2007

Last updated: November 2, 2012

Last verified: November 2012

History of Changes

Purpose

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

Condition	Intervention	Phase
End Stage Renal Disease	Device: Ardian Catheter	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Native Kidney Denervation in Patients With End Stage Renal Disease

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

U.S. FDA Resources

Further study details as provided by Medtronic Vascular:

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.

Study Start Date:

October 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551304

Locations

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

Sponsors and Collaborators

Medtronic Vascular

Investigators

Principal Investigator:

Markus Schlaich, MD

The Alfred Hospital

More Information

No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

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. Epub 2009 Oct 12. No abstract available.

ClinicalTrials.gov Identifier:	NCT00551304 History of Changes
Other Study ID Numbers:	TP-020 & TP-039
Study First Received:	October 26, 2007
Last Updated:	November 2, 2012
Health Authority:	Australia: Therapeutic Goods Administration

Additional relevant MeSH terms:

Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 21, 2013

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