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Single-arm Study of Symplicity™ Renal Denervation System in Patients With Uncontrolled HyperTensioN in India

NCT01632943 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-02-07

No results posted yet for this study

Summary

This study is to evaluate efficacy and safety of renal denervation in the treatment of uncontrolled hypertension. This study will enroll a minimum of 40 and a maximum of 45 subjects. The study will be conducted at up to 8 actively enrolling investigational sites. The primary endpoint is change in Office Systolic Blood Pressure from baseline to 6 months post-procedure.

Conditions

  • Adults With Uncontrolled Hypertension

Interventions

DEVICE

Symplicity renal denervation system

Previous research has shown that disrupting the nerves of the kidney may successfully decrease blood pressure. A less invasive approach to disrupting these nerves is to apply a brief high temperature near the nerves (renal denervation). This can now be done with an experimental medical device called the Symplicity renal denervation system. The System includes a catheter that is inserted into your blood vessels and an RF-generator.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Vascular

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-11-30
Completion
2014-12-31

Countries

  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01632943 on ClinicalTrials.gov