Renal Denervation in Patients With Advanced Heart Failure

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Standard steerable Marinr RF ablation Catheter (5F or 7F)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: renal denervation<br>in this group percutaneous renal denervation with Standard steerable Mariner Radiofreqency ablation Catheter (5F or 7F) | Device: Standard steerable Marinr RF ablation Catheter (5F or 7F)<br>* Intervention: Device: Standard steerable Mariner Radiofrequency ablation Catheter (5F or 7F)<br>* Other names: Renal ablation;|
| No Intervention: medical thrapy<br>medical treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal denervation, heart failure