Native Kidney Denervation in Patients With End Stage Renal Disease

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Medtronic

Status and phase

Completed
Phase 1

Conditions

End Stage Renal Disease

Treatments

Device: Ardian Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT00551304
TP-020 & TP-039

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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