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

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ClinicalTrials.gov Identifier: NCT01392196
Recruitment Status : Terminated (No evidence of a physiological response; no significant safety concerns; post 24-month follow-up; Data Monitoring Committee agreed)
First Posted : July 12, 2011
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure Procedure: Renal Denervation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment
Study Start Date : October 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Single arm
Renal Denervation
 Procedure: Renal Denervation
Renal Denervation using the Symplicity Catheter in Heart Failure Population


Outcome Measures
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Primary Outcome Measures :
  1. Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events [ Time Frame: 6 month ]

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

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01392196     History of Changes
Other Study ID Numbers: TP085
First Posted: July 12, 2011    Key Record Dates
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