Renal Denervation in Patients With Advanced Heart Failure

Phase 3 Study of Renal Denervation That Improves Symptoms of Heart Failure and Enhances Life Quality in Advanced Heart Failure

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01538992

Enrollment

Registered

2012-02-27

Start date

2013-04-30

Completion date

2014-04-30

Last updated

2013-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

renal denervation, heart failure

Brief summary

Sympathetic system has important role occurrence of symptoms in heart failure. Renal denervation that is ablated some of sympathetic nerves is affected pathology of heart failure. This interventional therapy improves symptoms and life quality.

Detailed description

Primary Outcome Measures: • Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events Secondary Outcome Measures: • Ventricular function,NYHA functional Class, 6 min walking test, biochemical test and Renal function as measured by Glomerular Filtration Rate (GFR) Eligibility Patients population: Volunteers, NYHA Class III-IV heart failure patients. Ages Eligible for Study: 18 Years to 85 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Interventions

DEVICEStandard steerable Marinr RF ablation Catheter (5F or 7F)

Intervention: Device: Standard steerable Mariner Radiofrequency ablation Catheter (5F or 7F)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Heart Failure patients NYHA Class III or IV * Left Ventricular Ejection Function \< 35% * GFR \> 45 mL/min/1.73m2 * Optimal stable medical therapy

Exclusion criteria

* Do not eligible renal artery anatomy 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 \< 110mmHG Hospitalisation because of heart failure in last 3 weeks.

Design outcomes

Primary

Measure	Time frame
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events	6 months

Secondary

Measure	Time frame
• Ventricular function as measured by Echocardiography • NYHA functional Class, 6 min walking test, biochemical test. • Renal function as measured by Glomerular Filtration Rate (GFR)	6 months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026