Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial (SymplicityHF)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medtronic Vascular Identifier:
First received: July 7, 2011
Last updated: April 13, 2016
Last verified: April 2016
This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe and determine the evidence of a response to renal denervation in patients with Heart Failure.

Condition Intervention Phase
Heart Failure
Procedure: Renal Denervation
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment

Resource links provided by NLM:

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ventricular function as measured by Echocardiography [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Renal function as measured by Glomerular Filtration Rate (GFR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: October 2011
Estimated Study Completion Date: July 2016
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm
Renal Denervation
Procedure: Renal Denervation
Renal Denervation using the Symplicity Catheter in Heart Failure Population


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Heart Failure patients NYHA Class II or III
  • Renal Impairment Left Ventricular Ejection Function <40%
  • GFR 30 to 75 mL/min/1.73m2
  • Optimal stable medical therapy

Exclusion Criteria:

  • Renal artery anatomy must be eligible for treatment as determined by Angiography, and
  • History of prior renal artery intervention
  • Single functioning kidney.
  • Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
  • Systolic BP < 90 mmHG
  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 identifier: NCT01392196

Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia
Sponsors and Collaborators
Medtronic Vascular
Principal Investigator: Henry Krum, MD The Alfred
  More Information

Responsible Party: Medtronic Vascular Identifier: NCT01392196     History of Changes
Other Study ID Numbers: TP085 
Study First Received: July 7, 2011
Last Updated: April 13, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Italy: Ministry of Health
Sweden: Medical Products Agency
Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medtronic Vascular:
Renal Impairment

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Cardiovascular Diseases
Heart Diseases
Kidney Diseases
Urologic Diseases processed this record on May 25, 2016