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Renal Denervation in Patients With Refractory Hypertension (HTN-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00664638
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Description
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Brief Summary:
To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Device: Symplicty(TM) Catheter System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Refractory Hypertension
Study Start Date : April 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Device: Symplicty(TM) Catheter System
    Renal denervation using the Symplicity Catheter System

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. To document the physiologic effects of renal denervation in patients with refractory hypertension. [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664638


Locations
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Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
St. Elisabeth Hospital
Bochum, Germany
Klinikum Coburg
Coburg, Germany
Universitaetsklinikum Duesseldorf
Duesseldorf, Germany
University of Erlangen at Nuremburg
Erlangen, Germany
CardioVascular Center Frankfurt, Sankt Katharinen
Frankfurt, Germany
Clinical Trial Center North
Hamburg, Germany
Universitatskliniken des Saarlandes
Homburg, Germany
University of Leipzig - Herzzentrum
Leipzig, Germany
Sponsors and Collaborators
Medtronic Vascular
Investigators
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Principal Investigator: Henry Krum, PhD Monash University and The Alfred Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00664638    
Other Study ID Numbers: TP-037
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases