Renal Denervation in Patients With Refractory Hypertension

Hypertension Clinical Trial

Official title:

Renal Denervation in Patients With Refractory Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483808
• Other study ID #: TP-015 & TP-038
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2007
• Last updated: November 1, 2013
• Start date: June 2007
• Est. completion date: May 2013

Study information

• Verified date: November 2013
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Aging Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• renal arterial abnormalities

• end stage renal disease requiring dialysis or renal transplant

• serum Cr > 3, or calculated GFR < 45 ml/min

• has experienced MI, unstable angina pectoris, or CVA with 6 months

• others

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Ardian Symplicity™ Catheter
Renal denervation using the Symplicity Catheter

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital	Fitzroy	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Poland	John Paul II Hospital	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Countries where clinical trial is conducted

Australia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide confirmation that renal denervation is safe and feasible.		3 years	Yes
Secondary	Evidence of renal denervation; indication of physiologic response; assessment of device performance.		3 years	No