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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00664638
First received: April 21, 2008
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Hypertension
Device: Symplicty(TM) Catheter System

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Refractory Hypertension

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To document the physiologic effects of renal denervation in patients with refractory hypertension. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: April 2008
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Symplicty(TM) Catheter System
    Renal denervation using the Symplicity Catheter System
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664638

Locations
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
Principal Investigator: Henry Krum, PhD Monash University and The Alfred Hospital
  More Information

No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00664638     History of Changes
Other Study ID Numbers: TP-037
Study First Received: April 21, 2008
Last Updated: November 1, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014