Renal Denervation in Patients With Refractory Hypertension

This study is currently recruiting participants.

Verified by Ardian Inc, September 2008

First Received: September 12, 2008 Last Updated: September 15, 2008 History of Changes

Sponsored by:	Ardian Inc
Information provided by:	Ardian Inc
ClinicalTrials.gov Identifier:	NCT00753285

Purpose

The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.

Condition	Intervention	Phase
Hypertension	Device: Renal Denervation with a catheter-based procedure	Phase I

MedlinePlus related topics: High Blood Pressure

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

Further study details as provided by Ardian Inc:

Primary Outcome Measures:

Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events. [ Time Frame: Through 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Physiologic response to renal denervation (e.g., blood pressure reduction) [ Time Frame: Through 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Disruption of the renal nerves with a catheter-based procedure.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753285

Locations

United States, Minnesota
Hennepin County Medical Center	Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Bradley Bart, MD 612-873-3000
Principal Investigator: Bradley Bart, MD

Sponsors and Collaborators

Ardian Inc

More Information

No publications provided

Responsible Party:	Ardian, Inc. ( Craig Straley, Vice President Clinical Research )
Study ID Numbers:	TP-040
Study First Received:	September 12, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00753285 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009