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Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

This study is currently recruiting participants.
Verified April 2013 by Medtronic Vascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01699529
First received: September 21, 2012
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Uncontrolled Hypertension
 Device: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Acute safety as measured by procedural complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Office Systolic Blood Pressure [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699529

Contacts
Contact: K Wandrey rs.medtroniccardiovascularclinicaltrials@medtronic.com

Locations
Australia, Victoria
St. Vincent's Hospital Melbourne Recruiting
Melbourne, Victoria, Australia, 3065
Principal Investigator: Robert Whitbourn, MD            
Epworth Hospital Recruiting
Melbourne, Victoria, Australia, 3069
Principal Investigator: Antony Walton, MD            
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Principal Investigator: Antony Walton, MD            
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Robert Whitbourn, MD St Vincent's Hospital Melbourne
  More Information

No publications provided

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01699529     History of Changes
Other Study ID Numbers: 10058715DOC
Study First Received: September 21, 2012
Last Updated: April 19, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013