None listed
Conditions
Brief summary
Renal Denervation in Heart Failure (RDN HF) is a physician-initiated pilot study involving staff of the Cardiology, Radiology and Nephrology Departments of the John Hunter Hospital, Newcastle, NSW. RDN HF is a first-in-human clinical trial of catheter-based renal denervation in heart failure patients. It uses a TGA approved device called the EnligHTN System, manufactiured by St Jude Medical. The study aims to evaluate the safety of renal denervation using the device and the effectiveness of the technique in improving the symptoms of heart failure. This is a prospective, randomised, controlled single centre study that will enrol approximately 20 participants with symptomatic congestive heart failure despite maximal medical treatment.
Interventions
Catheter-based renal denervation which is a medical procedure using a device. In this study, a multi-electrode catheter-based renal denervation system known as the EnligHTN System, is used. The renal denervation catheter delivers radiofrequency (RF) energy through the wall of the blood vessels supplying the kidneys (renal arteries) in order to disrupt the sympathetic nerves that lead to the kidneys. Each electrode on the catheter may independently administer 8 W of power over 60 seconds per abl
Catheter-based renal denervation which is a medical procedure using a device. In this study, a multi-electrode catheter-based renal denervation system known as the EnligHTN System, is used. The renal denervation catheter delivers radiofrequency (RF) energy through the wall of the blood vessels supplying the kidneys (renal arteries) in order to disrupt the sympathetic nerves that lead to the kidneys. Each electrode on the catheter may independently administer 8 W of power over 60 seconds per ablation set. The number of ablation sets is determined by the number and area of vessels to be treated. The average duration of the overall procedure is 1 to 2 hours.
Sponsors
Dr Suku Thambar
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to comprehend requirements and provide consent. 2. Males or females greater than or equal to 18years. 3. Established congestive heart failure with NYHA Class II-III 4. Left Ventricular Ejection Fraction (LVEF) less than or equal to 35% on echocardiography. 5. Adequate renal function with estimated GFR greater than or equal to 30 mL/min. 6. Optimal stable medical therapy for heart failure for at least 3 months prior to study entry as per ACCF/AHA guidelines.
Exclusion criteria
1. Renal artery abnormalities (i.e. too small, presence of significant stenosis, prior angioplasty procedure, multiple main renal arteries). 2. Single functioning kidney. 3. End Stage Renal Disease requiring haemo-dialysis or renal transplant. 4. Unstable vascular syndromes, such as myocardial infarction, unstable angina pectoris or cerebro-vascular accident, within 3 months. 5. Systolic blood pressure less than 100mmHg. 6. Haemodynamically significant valvular heart disease. 7. Pregnant, nursing or planning on becoming pregnant during the course of the study. 8. Enrolled in, or intend to participate in, another investigational drug or device trial. 9. Any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
Outcome results
None listed