NCT Number: NCT00551304
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).
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Notify MeKey information
Conditions
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
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.
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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.
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