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A prospective, multicenter, single arm, open-label, feasibility study to evaluate the safety

UCI Specialty Area: Other
Principal Investigator: Pengbo Jiang
Official Title: A prospective, multicenter, single arm, open-label, feasibility study to evaluate the safety and initial effectiveness of HyperQure RDN System, laparoscopic renal denervation therapy, in patients with hypertension in the absence of antihypertensive medications (Off-Med)
A Study On:
Other

Study Description

The purpose of this single arm interventional study is to evaluate initial safety and device design concept of HyperQureTM, laparoscopic(extravascular) renal denervation therapy, in patients with resistant hypertension on 3 or more antihypertensive medications including a diuretic The results of this study will be used to 1) prove the concept of complete ablation by Extravascular RDN and 2) develop a solid reference for a pivotal study

The HyperQureTM RDN System is developed to overcome the limitations of intravascular RDN using catheters; 1)incomplete renal denervation, 2) risk of endothelial damage due to heat transfer from inside blood vessels by intravascular access, and 3) access limitations due to vascular anatomy and vessel size.

The HyperQureTM RDN System is accessed through the vascular adventitia where renal sympathetic nerves are mainly distributed by retroperitoneal laparoscopic(extravascular) approach . Since the energy is transmitted from outside of vessel by wrapping the blood vessel 360 degrees and the instrument is applicable to small vessels including branch and/or accessory vessels, it is expected that it will be possible to achieve more complete renal denervation, reduce the risk of endothelial damage, and resolve structural access limitations.

Fifteen eligible adult men and women with resistant hypertension will be enrolled and will have Extravascular(laparoscopic) RDN under general anesthesia and will have 36month follow up with various BP evaluations(24hABP, Office BP and Home BP) and CTA/DUS imaging scan evaluations

Eligibility

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

  1. Aged greater than or equal to 22 and less than or equal to 80 years old at time of enrollment (consent).
  2. Diagnosed with resistant hypertension.
  3. Office BP greater than or equal to 140/90 mmHg at Screening Visit 13, and on at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent.
  4. Daytime ABP greater than or equal to 135/85 mmHg after a four (4)-week run-in period at Screening Visit 23.
  5. Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.

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:

a. Unstable angina with stent implantation (percutaneous coronary intervention) within 3 months of enrolment.

b. Myocardial infarction within 3 months of enrollment.

c. Acute heart failure (New York Heart Association (NYHA) III-IV) within 3 months of enrollment

d. Cerebrovascular accident or transient ischemic attack within 3 months of enrollment.

e. 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

  1. 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. A single functioning kidney.

b. An atheroma, aneurysm or renal artery stent within 5 mm of the renal denervation site.

c. Presence of stenosis of 30% or more on all of the blood vessels available for renal denervation

therapy.

d. When it is deemed impossible to perform denervation on both renal arteries according to the

discretion of the investigator.

  1. Has one or more of the following medical history or a history of surgery/procedure that is not suitable for renal denervation therapy

a. Renal denervation therapy.

b. Polycystic kidney disease (PKD).

c. Atrophic kidney.

d. Kidney transplant.

e. Dialysis due to end-stage renal disease.

f. Any surgery performed on both kidneys.

g. FMD (Fibromuscular dysplasia)

  1. Has comorbidities or surgical/procedural history that are not suitable for retroperitoneal

approach

a. Surgical history through retroperitoneal approach.

b. Fibrosis in the retroperitoneal region.

c. Inflammation in the retroperitoneal region.

d. Severe obesity (body mass index (BMI) > 40 kg/m2)

e. Risk of increased intracranial pressure

  1. Has a history of any intervention for underlying renal artery pathology including stenting or balloon angioplasty.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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