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Clinical Trials/NCT00483808
NCT00483808
Completed
Phase 1

Renal Denervation in Patients With Refractory Hypertension

Medtronic Vascular3 sites in 2 countries73 target enrollmentJune 2007
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ConditionsHypertension

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hypertension
Sponsor
Medtronic Vascular
Enrollment
73
Locations
3
Primary Endpoint
To provide confirmation that renal denervation is safe and feasible.
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.

Registry
clinicaltrials.gov
Start Date
June 2007
End Date
May 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Medtronic Vascular
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •\>= 18 years of age.
  • •a systolic blood pressure of 160 mmHg or greater.
  • •receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening.
  • •agrees to have the study procedure(s) performed and additional procedures and evaluations, including repeat phlebotomy, imaging, urine analyses, and clinical examination.
  • •competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria

  • •renal arterial abnormalities
  • •end stage renal disease requiring dialysis or renal transplant
  • •serum Cr \> 3, or calculated GFR \< 45 ml/min
  • •has experienced MI, unstable angina pectoris, or CVA with 6 months

Outcomes

Primary Outcomes

To provide confirmation that renal denervation is safe and feasible.

Time Frame: 3 years

Secondary Outcomes

  • Evidence of renal denervation; indication of physiologic response; assessment of device performance.(3 years)

Study Sites (3)

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