Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Uncontrolled Hypertension
• Intervention / Treatment: Device: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital
    • Melbourne, Victoria, Australia, 3065
      • St. Vincent's Hospital Melbourne
    • Melbourne, Victoria, Australia, 3069
      • Epworth Hospital
• New Zealand
  • Wellington, New Zealand
    • Wellington Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Renal Denervation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acute safety as measured by procedural complications	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Office Systolic Blood Pressure	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Medtronic Vascular
• Investigators: Principal Investigator: Robert Whitbourn, MD, St Vincent's Hospital Melbourne

Publications and helpful links

General Publications

• Whitbourn R, Harding SA, Walton A. Symplicity multi-electrode radiofrequency renal denervation system feasibility study. EuroIntervention. 2015 May;11(1):104-9. doi: 10.4244/EIJV11I1A18.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (ESTIMATE): October 3, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 10058715DOC