Native Kidney Denervation in Patients With End Stage Renal Disease

This study is currently recruiting participants.

Verified by Ardian Inc, April 2008

Sponsored by:	Ardian Inc
Information provided by:	Ardian Inc
ClinicalTrials.gov Identifier:	NCT00551304

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Native Kidney Denervation in Patients With End Stage Renal Disease

Further study details as provided by Ardian Inc:

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

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	Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Markus Schlaich, MD 61 3 8532 1502 Markus.Schlaich@baker.edu.au
Principal Investigator: Markus Schlaich, MD
Poland
John Paull II Hosptial	Recruiting
Cracow, Poland
Contact: Krzysztof Bartus, MD cool_chris@interial.pl
Principal Investigator: Jerzy Sadowski, MD, PhD

Sponsors and Collaborators

Ardian Inc

Investigators

Principal Investigator:

Markus Schlaich, MD

The Alfred Hospital

More Information

Study ID Numbers:	TP-020 & TP-039
Study First Received:	October 26, 2007
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00551304
Health Authority:	Australia: Therapeutic Goods Administration

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 15, 2009