Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

Not Applicable

Completed

• Conditions: Uncontrolled Hypertension
• Interventions: Device: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system

• Registration Number: NCT01699529
• Lead Sponsor: Medtronic Vascular

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-03
• Primary Completion: 2014-03
• Status Verified: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal Denervation	Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system	-

Primary Outcome Measures

Name	Time	Method
Acute safety as measured by procedural complications	1 month

Secondary Outcome Measures

Name	Time	Method
Change in Office Systolic Blood Pressure	Baseline to 6 months

Trial Locations

Locations (4)

St. Vincent's Hospital Melbourne; 🇦🇺 Melbourne, Victoria, Australia

Epworth Hospital; 🇦🇺 Melbourne, Victoria, Australia

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Wellington Hospital; 🇳🇿 Wellington, New Zealand