Actively Recruiting
REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions.
Led by Royal Perth Hospital · Updated on 2023-01-30
75
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
Sponsors
R
Royal Perth Hospital
Lead Sponsor
R
ReCor Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The is a non-randomized pilot trial, open-label evaluation of the physiologic response of native kidney denervation using the Paradise denervation system in CKD, End Stage Renal Disease (ESRD), and Heart failure (HF)
CONDITIONS
Official Title
REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients
- Age between 18 and 75 years
- Able and willing to provide written informed consent
- Diagnosis of either CKD stage 3a or 3b, or ESRD on stable renal replacement therapy, or mild to moderate heart failure with reduced ejection fraction
You will not qualify if you...
- Ineligible kidney anatomy for the procedure
- Prior treatment with hypertension devices such as ROX Coupler, Mobius stent, or CVRx barostimulator
- Heart attack, unstable angina, or stroke within 3 months before screening
- Chronic active inflammatory bowel disease like Crohn's or ulcerative colitis
- Significant heart valve disease unless corrected with a working prosthetic valve
- Hospitalization for decompensated heart failure in the last month
- Female of childbearing potential without a negative pregnancy test before treatment
- History of drug or alcohol dependency, inability to follow instructions, or unlikely to comply with follow-up
- Currently enrolled in another investigational drug or device trial
- Disease or condition limiting life expectancy to less than 1 year (other than CKD, ESRD, or heart failure)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Actively Recruiting
Research Team
A
Anu Joyson
CONTACT
M
Markus Schlaich
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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