Actively Recruiting
Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension
Led by DeepQure Inc. · Updated on 2025-12-04
15
Participants Needed
5
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications
CONDITIONS
Official Title
Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 22 to 80 years old at enrollment
- Diagnosed with resistant hypertension
- Office blood pressure at least 140/90 mmHg while on at least 3 antihypertensive medications including a diuretic for at least 4 weeks
- Daytime ambulatory blood pressure at least 135/85 mmHg after a 4-week run-in period
- Willing and able to provide informed consent and complete study procedures
You will not qualify if you...
- Renal artery diameter less than 2 mm or greater than 11 mm
- Unstable angina with stent implantation within 3 months
- Myocardial infarction within 3 months
- Acute heart failure (NYHA III-IV) within 3 months
- Stroke or transient ischemic attack within 3 months
- Atrial fibrillation not in sinus rhythm
- Single functioning kidney
- Atheroma, aneurysm, or stent near treatment site
- Renal artery stenosis of 30% or more
- Impossible to perform denervation on both renal arteries
- History of renal denervation therapy
- Polycystic kidney disease, atrophic kidney, kidney transplant, or dialysis
- Surgery on both kidneys except for endoscopic procedures
- Fibromuscular dysplasia
- Surgical history or fibrosis/inflammation in retroperitoneal region
- Severe obesity (BMI > 40)
- Risk of increased intracranial pressure
- History of interventions for renal artery pathology
- eGFR less than 45 mL/min/1.73m2
- Type I diabetes or uncontrolled Type II diabetes (HbA1c ≥ 9.0%)
- Significant blood pressure drop with symptoms upon standing
- Requires chronic oxygen or mechanical ventilation other than sleep apnea support
- Documented primary pulmonary hypertension
- Untreated secondary hypertension or use of drugs increasing sympathetic tone
- Planned surgery that may affect study results
- Works night shifts
- Severe cardiac valve stenosis
- Pregnant, nursing, or planning pregnancy
- History of drug or alcohol dependency or unable to comply with study
- Bleeding disorders or refusal of blood transfusions
- High risk if anticoagulants or antiplatelet agents are stopped
- Allergy or intolerance to contrast medium
- Recent start of cardiovascular medications posing serious health risk if stopped
- Frequent use of NSAIDs for pain
- Enrolled in other investigational drug or device studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
2
Stanford Health Care
Stanford, California, United States, 94305
Actively Recruiting
3
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
Actively Recruiting
4
Henry Forth Health
Detroit, Michigan, United States, 48202
Actively Recruiting
5
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
A
Aeyoung Woo
CONTACT
J
Jaehung Jung, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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