Actively Recruiting
Early Feasibility Study of HyperQureTM Laparoscopic Renal Denervation Therapy in Patients With Resistant Hypertension on Three or More Medications
Led by DeepQure Inc. · Updated on 2025-12-04
15
Participants Needed
5
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and design of the HyperQureTM Renal Denervation (RDN) System in adults with resistant hypertension who are taking three or more blood pressure medications including a diuretic. This early feasibility study aims to prove the concept of complete ablation through an extravascular laparoscopic approach and to inform a future pivotal study. The HyperQureTM system seeks to overcome limitations of current catheter-based renal denervation by accessing the renal artery from outside the vessel, potentially reducing risks and improving treatment success. Participants will undergo laparoscopic extravascular renal denervation under general anesthesia using the HyperQureTM device. The procedure involves wrapping the renal artery 360 degrees and delivering radiofrequency energy to ablate nerves controlling blood pressure. The study uses pre-procedure CT angiography to plan treatment areas on the main renal arteries and suitable branch vessels. Fifteen patients will be treated in this single-arm study. After the procedure, participants will be followed for 36 months with regular evaluations including 24-hour ambulatory blood pressure monitoring, office and home blood pressure checks, and imaging with CT angiography and Doppler ultrasound. Researchers will measure changes in systolic and diastolic blood pressure, rates of adverse events, and other safety outcomes. This long follow-up will help assess the initial safety and effectiveness of the laparoscopic renal denervation procedure.
CONDITIONS
Brief 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 at enrollment
- Diagnosed with resistant hypertension
- Office blood pressure of 140/90 mmHg or higher at screening
- On at least three antihypertensive medications including a diuretic for at least 4 weeks prior to consent
- Daytime ambulatory blood pressure of 135/85 mmHg or higher after a 4-week run-in period
- Willing and able to provide written informed consent and undergo all 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 or unsuitable renal artery anatomy
- History of renal denervation therapy
- Polycystic kidney disease, atrophic kidney, kidney transplant, or dialysis
- Prior surgery on both kidneys (except endoscopic stone removal)
- Fibromuscular dysplasia
- Surgical history or fibrosis/inflammation in retroperitoneal region
- Severe obesity (BMI > 40 kg/m2)
- Increased intracranial pressure risk
- Prior renal artery interventions (stenting or angioplasty)
- eGFR below 45 mL/min/1.73m2
- Type I diabetes or uncontrolled Type II diabetes (HbA1c ≥ 9.0%)
- Orthostatic blood pressure drop with symptoms
- Chronic oxygen or mechanical ventilation support (except sleep apnea devices)
- Primary pulmonary hypertension
- Untreated secondary hypertension or medications increasing sympathetic tone
- Planned surgery affecting study endpoints
- Night shift workers
- Severe cardiac valve stenosis
- Pregnancy, nursing, or planning pregnancy during study
- History of drug or alcohol dependency or inability to comply
- Bleeding disorders or refusal of blood transfusions
- High risk if anticoagulants are stopped
- Allergies to contrast medium
- Recent cardiovascular medication changes posing health risks
- Frequent use of NSAIDs for pain
- Concurrent enrollment in other investigational drug or device studies (except registries)
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo laparoscopic renal denervation therapy using the HyperQureTM RDN System under general anesthesia.
1 procedure visit (in-person)
Duration - 36 months
Participants are monitored with blood pressure evaluations and imaging scans to assess safety and treatment effects.
Multiple visits over 36 months including 24-hour ambulatory BP, office BP, home BP measurements, and CTA/DUS imaging
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
J
Jaehung Jung, MD
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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