Native Kidney Denervation in Patients With End Stage Renal Disease

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

Completed

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Alfred Hospital, Melbourne, Victoria, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ardian Catheter

Device

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Important dates

Study start: 2007
First posted: Oct 30, 2007
Registry last updated: Nov 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed