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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

Tracking Information
First Submitted Date  ICMJE April 21, 2008
First Posted Date  ICMJE April 23, 2008
Last Update Posted Date November 5, 2013
Study Start Date  ICMJE April 2008
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 21, 2008)
To provide confirmation that renal denervation is safe and feasible.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2012)
To document the physiologic effects of renal denervation in patients with refractory hypertension. [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2008)
Indication of physiologic response and assessment of device performance
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Renal Denervation in Patients With Refractory Hypertension
Official Title  ICMJE Renal Denervation in Patients With Refractory Hypertension
Brief Summary To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Device: Symplicty(TM) Catheter System
Renal denervation using the Symplicity Catheter System
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2010)
45
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00664638
Other Study ID Numbers  ICMJE TP-037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Vascular
Study Sponsor  ICMJE Medtronic Vascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Henry Krum, PhD Monash University and The Alfred Hospital
PRS Account Medtronic Vascular
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP