Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

Uncontrolled Hypertension Clinical Trial

Official title:

Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699529
• Other study ID #: 10058715DOC
• Status: Completed
• Phase: N/A
• First received: September 21, 2012
• Last updated: October 24, 2016
• Start date: September 2012
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2016
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Individual is = 18 and = 80 years old.

• Individual has an office systolic blood pressure of 160 mmHG or greater (= 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings

• Individual is adhering to a stable medication regimen including = 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening.

Exclusion Criteria:

• Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2

• Individual has type 1 diabetes mellitus

• Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.

• Individual has primary pulmonary hypertension.

• Individual is pregnant, nursing or planning to be pregnant.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

Device:
• Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system
The Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator.

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Epworth Hospital	Melbourne	Victoria
Australia	St. Vincent's Hospital Melbourne	Melbourne	Victoria
New Zealand	Wellington Hospital	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute safety as measured by procedural complications		1 month	Yes
Secondary	Change in Office Systolic Blood Pressure		Baseline to 6 months	No