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

This study has been terminated.
(No evidence of a physiological response; no significant safety concerns; post 24-month follow-up; Data Monitoring Committee agreed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01392196
First Posted: July 12, 2011
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Vascular
  Purpose
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
Heart Failure Procedure: Renal Denervation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Ventricular function as measured by Echocardiography [ Time Frame: 6 month ]
  • Renal function as measured by Glomerular Filtration Rate (GFR) [ Time Frame: 6 months ]

Enrollment: 39
Study Start Date: October 2011
Study Completion Date: June 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392196


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

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01392196     History of Changes
Other Study ID Numbers: TP085
First Submitted: July 7, 2011
First Posted: July 12, 2011
Last Update Posted: February 1, 2017
Last Verified: January 2017

Keywords provided by Medtronic Vascular:
Renal Impairment

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases