Renal Denervation in Patients With Refractory Hypertension - Full Text View

Sponsor:	Ardian Inc
Information provided by:	Ardian Inc
ClinicalTrials.gov Identifier:	NCT00483808

Purpose

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

Condition	Intervention	Phase
Refractory Hypertension	Device: Ardian Symplicity™ Catheter	Phase I

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Renal Denervation in Patients With Refractory Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

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:

Evidence of renal denervation; indication of physiologic response; assessment of device performance. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	73
Study Start Date:	June 2007
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 Renal denervation using the Symplicty Catheter	Device: Ardian Symplicity™ Catheter Renal denervation using the Symplicity Catheter

Eligibility

Criteria

Inclusion Criteria:

>= 18 years of age.
a systolic blood pressure of 160 mmHg or greater.
receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening.
agrees to have the study procedure(s) performed and additional procedures and evaluations, including repeat phlebotomy, imaging, urine analyses, and clinical examination.
competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483808

Locations

Australia, Victoria
St. Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Poland
John Paul II Hospital
Cracow, Poland

Sponsors and Collaborators

Ardian Inc

Investigators

Principal Investigator:	Henry Krum, MBBS,PhD	The Alfred Hospital and Monash University, Melbourne, VIC, Australia
Principal Investigator:	Robert Whitbourn, MBBS, FRACP	St. Vincent's Hospital, Fitzroy, VIC, Australia

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 of Clinical Affairs, Ardian
ClinicalTrials.gov Identifier:	NCT00483808 History of Changes
Other Study ID Numbers:	TP-015 & TP-038
Study First Received:	June 5, 2007
Last Updated:	September 24, 2010
Health Authority:	Australia: Department of Health and Aging Therapeutic Goods Administration

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012