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Clinical Trials/NCT00753285
NCT00753285
Completed
Not Applicable

Renal Denervation in Patients With Refractory Hypertension

Medtronic Vascular3 sites in 1 country35 target enrollmentSeptember 2008
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Medtronic Vascular
Enrollment
35
Locations
3
Primary Endpoint
Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
May 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Medtronic Vascular
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Systolic blood pressure of 160 mmHg or greater
  • On 3 or more antihypertensive medications
  • eGFR \>= 45 mL/min

Exclusion Criteria

  • Renal artery abnormalities
  • Known secondary hypertension attributable to a cause other than sleep apnea
  • MI, angina, CVA within 6 months
  • Type 1 diabetes

Outcomes

Primary Outcomes

Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.

Time Frame: Through 3 years

Secondary Outcomes

  • Physiologic response to renal denervation (e.g., blood pressure reduction)(Through 3 years)

Study Sites (3)

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