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OpenTrials
Completed

NCT Number: NCT00664638

Renal Denervation in Patients With Refractory Hypertension

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herzzentrum Bad Krozingen, Bad Krozingen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >= 18 years of age
  • a systolic blood pressure of 160mmHg or more
  • receiving and adhering to full doses of at least three antihypertensive drugs
  • estimated glomerular filtration rate (eGFR) of ≥45mL/min
  • agrees to have the study procedure(s) performed and additional procedures and evaluations
  • is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion criteria

  • hemodynamically or anatomically significant renal artery stenosis
  • has a history or prior renal artery angioplasty
  • has experienced MI, unstable angina pectoris, or CVA within 6 months
  • has hemodynamically significant valvular heart disease
  • has Type 1 diabetes
  • has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
  • requires respiratory support
  • is pregnant, nursing, or planning to be pregnant
  • has known, unresolved history of drug use or alcohol dependency.
  • is currently enrolled in another investigational drug or device trial.

Treatment and study plan

Symplicty(TM) Catheter System

Device

Renal denervation using the Symplicity Catheter System

Primary outcomes

  1. To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension.

    Time frame: 3 years

Secondary outcomes

  1. To document the physiologic effects of renal denervation in patients with refractory hypertension.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Acronym: HTN-1

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 23, 2008
Registry last updated
Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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