Renal Denervation in Patients With Advanced Heart Failure

Bursa Postgraduate Hospital

Status and phase: Withdrawn; Phase 3

Conditions: Heart Failure

Treatments: Device: Standard steerable Marinr RF ablation Catheter (5F or 7F)

Study type: Interventional

Funder types: Other

Identifiers

NCT01538992

Bursa YİEAH

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

renal denervation

Experimental group

Description:

in this group percutaneous renal denervation with Standard steerable Mariner Radiofreqency ablation Catheter (5F or 7F)

Treatment:

Device: Standard steerable Marinr RF ablation Catheter (5F or 7F)

medical thrapy

No Intervention group

Description:

medical treatment