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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Procedure: Renal Denervation | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Single arm
Renal Denervation
|
Procedure: Renal Denervation
Renal Denervation using the Symplicity Catheter in Heart Failure Population
|
- Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events [ Time Frame: 6 month ]
- Ventricular function as measured by Echocardiography [ Time Frame: 6 month ]
- Renal function as measured by Glomerular Filtration Rate (GFR) [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Australia, Victoria | |
Alfred Hospital | |
Melbourne, Victoria, Australia |
Principal Investigator: | Henry Krum, MD | The Alfred |
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 |