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

Heart Failure Clinical Trial

— SymplicityHF  

Official title:

Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01392196
• Other study ID #: TP085
• Status: Terminated
• Phase: N/A
• First received: July 7, 2011
• Last updated: January 30, 2017
• Start date: October 2011
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Renal Insufficiency

Intervention

Procedure:
• Renal Denervation
Renal Denervation using the Symplicity Catheter in Heart Failure Population

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events		6 month
Secondary	Ventricular function as measured by Echocardiography		6 month
Secondary	Renal function as measured by Glomerular Filtration Rate (GFR)		6 months