Laparoscopic renal denervation therapy for resistant hypertension

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

This study is testing a new procedure to see if it can safely help people with hard-to-treat high blood pressure who are already taking multiple medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 22 Years to 80 Years
• Sex: All
• Sponsor: DeepQure Inc. (Industry-sponsored)
• Locations: 5 sites (Orange, California and 4 other locations)
• Trial ID: NCT06526858 on ClinicalTrials.gov

What this trial studies

This early feasibility study evaluates the safety and design of the HyperQureTM RDN System, a laparoscopic renal denervation therapy, in patients suffering from resistant hypertension who are on three or more antihypertensive medications. The study aims to demonstrate the effectiveness of complete renal denervation through an extravascular approach, which is expected to minimize risks associated with traditional intravascular methods. A total of fifteen eligible adult participants will undergo the procedure under general anesthesia, and the findings will inform future pivotal studies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 to 80 with resistant hypertension who are on three or more antihypertensive medications.

Not a fit: Patients with certain cardiovascular conditions or those whose renal artery diameter falls outside the specified range may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with resistant hypertension, potentially improving blood pressure control.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in renal denervation therapies, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

Subjects are eligible to participate if all of the following criteria are met:

1. Aged ≥22 and ≤80 years old at time of enrollment (consent).
2. Diagnosed with resistant hypertension.
3. 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.
4. Daytime ABP ≥135/85 mmHg after a four (4)-week run-in period at Screening Visit 2.
5. Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

Subjects are not eligible to participate if any of the following criteria are met:

1. Has coverage diameter of renal artery less than 2 mm or greater than 11 mm.
2. Has one or more of the following conditions:

   1. Unstable angina with stent implantation (percutaneous coronary intervention) within 3 months of enrolment.
   2. Myocardial infarction within 3 months of enrollment.
   3. Acute heart failure (New York Heart Association (NYHA) III-IV) within 3 months of enrollment
   4. Cerebrovascular accident or transient ischemic attack within 3 months of enrollment.
   5. 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
3. 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)

   1. A single functioning kidney.
   2. An atheroma, aneurysm or renal artery stent within 5 mm of the renal denervation site.
   3. Presence of stenosis of 30% or more on all of the blood vessels available for renal denervation therapy.
   4. When it is deemed impossible to perform denervation on both renal arteries according to the discretion of the investigator.
4. Has one or more of the following medical history or a history of surgery/procedure that is not suitable for renal denervation therapy

   1. Renal denervation therapy.
   2. Polycystic kidney disease (PKD).
   3. Atrophic kidney.
   4. Kidney transplant.
   5. Dialysis due to end-stage renal disease.
   6. Any surgery performed on both kidneys. (except endoscopy type of surgery, i.e. endoscopic kidney stone removal)
   7. FMD (Fibromuscular dysplasia)
5. Has comorbidities or surgical/procedural history that are not suitable for retroperitoneal approach

   1. Surgical history through retroperitoneal approach.
   2. Fibrosis in the retroperitoneal region.
   3. Inflammation in the retroperitoneal region.
   4. Severe obesity (body mass index (BMI) \> 40 kg/m2)
   5. Risk of increased intracranial pressure
6. Has a history of any intervention for underlying renal artery pathology including stenting or balloon angioplasty.
7. Individual has an eGFR of \<45 mL/min/1.73m2, using the 4 variable Modification of Diet in Renal Disease (MDRD) calculation (in mL/min) per 1.73 m2 = 175 x Serum Cr-1.154 x age-0.203 x 1.212 (if patient is black) x 0.742 (if female).
8. Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%).
9. Has had a reduction of SBP of ≥20 mm Hg or DBP of ≥10 mm Hg within 3 minutes of standing coupled with symptoms during the screening process (at Screening Visit 2).
10. Requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea (e.g., CPAP, BiPAP).
11. Has documented primary pulmonary hypertension.
12. Has an untreated secondary cause of hypertension (either known or suspected) or is taking drugs that increase sympathetic tone and could contribute to hypertension.
13. Has a scheduled or planned surgery that, in the opinion of the Investigator, may affect study endpoints.
14. Works night shifts.
15. Has severe cardiac valve stenosis for which, in the opinion of the Investigator, a significant reduction of blood pressure is contraindicated.
16. Is pregnant, nursing or planning to become pregnant during the course of the study follow-up (Note: Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography).
17. Has a known unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable, in the opinion of the Investigator, to comply with study follow-up requirements.
18. Has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
19. Patients who are at high risk if taken off their anticoagulant and antiplatelet agents for a few days.
20. Allergy, intolerance or contraindications to contrast medium.
21. Prescribed any standard antihypertensive cardiovascular medication for other chronic conditions (e.g. ischemic heart disease) for less than 90 days before Screening visit 1 and whose discontinuation might pose serious risk to health.
22. Has frequent intermittent or chronic pain that results in the treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for two (2) or more days per week over the month prior to Screening Visit 2.
23. Concurrent enrollment in any other investigational drug or device study(Participation in non-interventional Registries is acceptable).

Where this trial is running

Orange, California and 4 other locations

• University of California Irvine — Orange, California, United States (Recruiting)
• Stanford Health Care — Stanford, California, United States (Recruiting)
• University of Florida College of Medicine — Gainesville, Florida, United States (Recruiting)
• Henry Forth Health — Detroit, Michigan, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Study coordinator: Aeyoung Woo

Conditions Resistant Hypertension