Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01699529
First received: September 21, 2012
Last updated: May 28, 2014
Last verified: May 2014
  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:


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 ]

Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: August 2016
Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia, Victoria
St. Vincent's Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Epworth Hospital
Melbourne, Victoria, Australia, 3069
Alfred Hospital
Melbourne, Victoria, Australia, 3004
New Zealand
Wellington Hospital
Wellington, New Zealand
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: May 28, 2014
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 August 28, 2014