Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension
Recruiting now · Not applicable
Conditions studied: Resistant Hypertension
In brief
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
Key facts
- Study ID
- NCT06526858
- Run by
- DeepQure Inc.
- People needed
- 15
- Starts
- 2024-11-21
- Expected to finish
- 2029-03-20
- Last updated by the study team
- 2025-12-04
Who can join
Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects are eligible to participate if all of the following criteria are met:
- Aged ≥22 and ≤80 years old at time of enrollment (consent).
- Diagnosed with resistant hypertension.
- Office BP ≥140/90 mmHg at Screening Visit 1, and on at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent.
- Daytime ABP ≥135/85 mmHg after a four (4)-week run-in period at Screening Visit 2.
- Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
You may not qualify if…
- Subjects are not eligible to participate if any of the following criteria are met:
- Has coverage diameter of renal artery less than 2 mm or greater than 11 mm.
- Has one or more of the following conditions:
- Unstable angina with stent implantation (percutaneous coronary intervention) within 3 months of enrolment.
- Myocardial infarction within 3 months of enrollment.
- Acute heart failure (New York Heart Association (NYHA) III-IV) within 3 months of enrollment
- Cerebrovascular accident or transient ischemic attack within 3 months of enrollment.
- Atrial fibrillation patients undergoing treatment and not in sinus rhythm. Notes: Patients who have received medical treatment, catheter or surgical treatment for atrial fibrillation and are in sinus rhythm are not excluded
- Has one or more of the following confirmed anatomical findings in the kidney or renal artery that are not suitable for renal denervation (assessed by the renal CT angiography of Screening 2)
- A single functioning kidney.
- An atheroma, aneurysm or renal artery stent within 5 mm of the renal denervation site.
- Presence of stenosis of 30% or more on all of the blood vessels available for renal denervation therapy.
- When it is deemed impossible to perform denervation on both renal arteries according to the discretion of the investigator.
- Has one or more of the following medical history or a history of surgery/procedure that is not suitable for renal denervation therapy
- Renal denervation therapy.
- Polycystic kidney disease (PKD).
- Atrophic kidney.
- Kidney transplant.
- Dialysis due to end-stage renal disease.
- Any surgery performed on both kidneys. (except endoscopy type of surgery, i.e. endoscopic kidney stone removal)
- FMD (Fibromuscular dysplasia)
- Has comorbidities or surgical/procedural history that are not suitable for retroperitoneal approach
- Surgical history through retroperitoneal approach.
- Fibrosis in the retroperitoneal region.
- Inflammation in the retroperitoneal region.
Where it is running
- University of California Irvine — Orange, California, United States (enrolling)
- Stanford Health Care — Stanford, California, United States (enrolling)
- University of Florida College of Medicine — Gainesville, Florida, United States (enrolling)
- Henry Forth Health — Detroit, Michigan, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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