The DeLIVER NZ Study will evaluate the safety of the Integrated Radio Frequency (iRF) Denervation System which is designed to improve blood pressure in patients with hypertnesion.

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes Mellitus; Hypertension; Metabolic and Endocrine - Diabetes; Cardiovascular - Hypertension; Metabolic and Endocrine - Other metabolic disorders; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12619001524189
• Lead Sponsor: Metavention, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-05
• Last Update Posted: 16 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1)Age greater than or equal to 22 and less than or equal to 70 years old
2)Waist circumference greater than or equal to 102 cm (male) and greater than or equal to 88 cm (female)
3)Office systolic blood pressure (SBP) greater than or equal to 140 mmHg and less than 180 mmHg on a stable dose of antihypertensive medication(s) for at least 30 days
4)Documented daytime systolic ambulatory blood pressure (ABP) greater than or equal to 135 and less than 175 mmHg
5)Documented status of stable lifestyle modifications
6)Willing to comply with study requirements, including follow-up visits
7)Women of childbearing potential (WOCBP) must be using at least one acceptable method of contraception throughout the study

Exclusion Criteria

8)BMI of greater than 40 kg/m2
9)Type 1 diabetes mellitus or uncontrolled Type 2 diabetes (uncontrolled defined as HbA1c greater than 8.5 % / 69 mmol/mol)
10)One or more documented hyperglycemia episodes (requiring hospitalization) in the 90 days prior to Index Procedure
11)One or more severe hypoglycemic events (severe cognitive impairment requiring external assistance for recovery) in the 90 days prior to Index Procedure
12)One or more documented severe hypertensive crisis (persistent or elevated hypertension greater than 180 mmHg accompanied by clinical symptoms) in the 90 days prior to Index Procedure
13)A history of bariatric surgery, renal denervation, baroreflex activation therapy, or liver transplant, or these procedures are planned in the 365 days following Index Procedure
14)Any surgical procedure within 30 days prior to Index Procedure
15)History of or current symptomatic gallstones (e.g., cholecystitis, bile duct dilatation) without a cholecystectomy being performed(Note: subjects who have had a cholecystectomy are not excluded)
16)Previous hepatobiliary surgery/intervention that in the opinion of the investigator could preclude the ability to perform denervation of the common hepatic artery
17)Use of anticoagulation therapy which cannot be discontinued from 7 days before to 14 days after the Index Procedure
18)Any other condition(s) that would compromise the safety of the Subject or compromise study quality as judged by the Investigator
19)eGFR less than 45 mL/min/1.73 m2
20)History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy (e.g., orthostatic hypotension attributable to autonomic neuropathy, a diagnosis of gastroparesis, or a clinical history strongly suggestive of delayed gastric emptying)
21)Myocardial infarction, unstable angina, stroke, or transient ischemic attack within the 180 days prior to Baseline, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques
22)Heart failure (New York Heart Association [NYHA] Class III-IV) at time of consent
23)Documented history of persistent or permanent atrial tachyarrhythmia
24)Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
25)Night shift workers
26)Chronic regular use (e.g., daily use) of NSAIDs for 6 months or greater. Aspirin therapy is allowed.
27)Active implantable medical device (e.g., ICD or CRT-D, neuromodulator/spinal stimulator, baroreflex stimulator)
28)Known primary pulmonary HTN (greater 60 mmHg pulmonary artery or right ventricular systolic pressure)
29)Evidence of active infection within 7 days prior to Index Procedure
30)Documented history of chronic active inflammatory bowel disorders such as Crohn’s disease or ulcerative colitis
31)Individual has known pheochromocytoma, Cushing syndrome, primary hyperaldosteronism, coarctation of the aorta, untreated hyperthyroidism, untreated hypothyroidism, or primary hyperparathyroidism. (Note: Treated hyperthyroidism and treated hypothyroidism are permissible.)
32)Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count <100,000/microliter, or documented coagulopathy
33)Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requi

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence rate of device related serious adverse device effects (SADEs) from time of Index Procedure through 90 days.<br>Some potential adverse events include but are not limited to: post operative pain, hematoma at the access site, tenderness and swelling at the catheter insertion site, allergic reaction to materials used, high or low blood pressure or damage to the liver. All events will be assessed using a variety of methods including: monitoring of vital signs, blood labs, glucose testing, imaging and self-reporting. Patients will be closely monitored by the study physician throughout study participation. [90 days post procedure]