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Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4

NCT01972139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-04-26

No results posted yet for this study

Summary

An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.

Conditions

Interventions

DEVICE

Renal Denervation using the Symplicity Renal Denervation System

Subjects randomized to the renal denervation group underwent angiography and renal denervation.

OTHER

Sham Renal Denervation

Prior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over.

DEVICE

Renal Angiography

Subjects who met all criteria after the screening period did undergo a renal artery angiogram to evaluate renal artery anatomy. Only subjects with eligible renal artery anatomy were randomized.

Sponsors & Collaborators

  • Medtronic Vascular

    lead INDUSTRY

Principal Investigators

  • David Kandzari, MD · Piedmont Heart Institute

  • Michael Weber, MD · SUNY Downstate College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-07-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01972139 on ClinicalTrials.gov