Renal Denervation in Refractory Hypertension

This study is currently recruiting participants.

Verified by Ardian Inc, April 2008

First Received: April 21, 2008 No Changes Posted

Sponsor:	Ardian Inc
Information provided by:	Ardian Inc
ClinicalTrials.gov Identifier:	NCT00664638

Purpose

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

Condition	Intervention	Phase
Refractory Hypertension End Stage Renal Disease	Device: Ardian Nerve Modulation System	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Renal Denervation in Patients With Refractory Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Further study details as provided by Ardian Inc:

Primary Outcome Measures:

Secondary Outcome Measures:

Study Start Date:	April 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

>= 18 years of age
a systolic blood pressure of 160mmHg or more
receiving and adhering to full doses of appropriate antihypertensive drug regimen
estimated glomerular filtration rate (eGFR) of ≥45mL/min, or has end stage renal disease (ESRD) and has been on dialysis for at least 6 months
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:

renal arterial abnormalities
has experienced MI, unstable angina pectoris, or CVA within 6 months
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
others

Contacts and Locations

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

Locations

Germany
CardioVascular Center Frankfurt, Sankt Katharinen	Recruiting
Frankfurt, Germany
Contact: Horst Sievert, MD HorstSievertMD@aol.com
Principal Investigator: Horst Sievert, MD

Sponsors and Collaborators

Ardian Inc

More Information

No publications provided by Ardian Inc

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Responsible Party:	Ardian, Inc. ( Craig Straley, Vice President, Clinical Affairs )
Study ID Numbers:	TP-037
Study First Received:	April 21, 2008
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00664638 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Kidney Failure, Chronic

Cardiovascular Diseases
Kidney Diseases
Kidney Failure
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010