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: April 13, 2016

Last verified: April 2016

History of Changes

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	Phase
Heart Failure	Procedure: Renal Denervation	Phase 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]


Enrollment:	39
Study Start Date:	October 2011
Estimated Study Completion Date:	July 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)
Genders Eligible for Study:	Both
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:	April 13, 2016
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Italy: Ministry of Health Sweden: Medical Products Agency Austria: Austrian Medicines and Medical Devices Agency

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 27, 2016

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