Renal Denervation in Refractory Hypertension

This study is ongoing, but not recruiting participants.

First Received on April 21, 2008. Last Updated on September 24, 2010 History of Changes

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: Symplicty(TM) Catheter System	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: High Blood Pressure Kidney Failure

U.S. FDA Resources

Further study details as provided by Ardian Inc:

Primary Outcome Measures:

To provide confirmation that renal denervation is safe and feasible. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Indication of physiologic response and assessment of device performance [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	45
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Denervation	Device: Symplicty(TM) Catheter System Renal denervation using the Symplicity Catheter System

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
Frankfurt, Germany

Sponsors and Collaborators

Ardian Inc

More Information

No publications provided by Ardian Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party:	Craig Straley, Vice President, Clinical Affairs, Ardian, Inc.
ClinicalTrials.gov Identifier:	NCT00664638 History of Changes
Other Study ID Numbers:	TP-037
Study First Received:	April 21, 2008
Last Updated:	September 24, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Hypertension
Kidney Diseases
Kidney Failure, Chronic
Vascular Diseases

Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on February 09, 2012