This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01392196
First received: July 7, 2011
Last updated: January 30, 2017
Last verified: January 2017
  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

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
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: 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
Study First Received: July 7, 2011
Last Updated: January 30, 2017

Keywords provided by Medtronic Vascular:
Renal Impairment

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

ClinicalTrials.gov processed this record on September 20, 2017