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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01392196
First received: July 7, 2011
Last updated: September 23, 2014
Last verified: September 2014

July 7, 2011
September 23, 2014
October 2011
February 2015   (final data collection date for primary outcome measure)
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01392196 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment

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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
Procedure: Renal Denervation
Renal Denervation using the Symplicity Catheter in Heart Failure Population
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
September 2017
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01392196
TP085
Yes
Medtronic Vascular
Medtronic Vascular
Not Provided
Principal Investigator: Henry Krum, MD The Alfred
Medtronic Vascular
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP