Evaluation of the Integrated Radio Frequency Denervation System for the Treatment of Hypertension (RADAR)

A Renal Artery Denervation Feasibility Study of the MetAvention Integrated Radio Frequency Denervation System for the Treatment of Hypertension

The objective of the study is to evaluate the safety of renal denervation using the iRF System and to understand any potential improvement in hypertension.

Study Overview

• Status: Completed
• Conditions: Hypertension; Metabolic Syndrome
• Intervention / Treatment: Device: iRF System Renal Denervation

Detailed Description

This study is a prospective, single-arm, multi-center, non-randomized trial to evaluate the initial safety and performance of renal denervation with the iRF system for the treatment of hypertension.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia, 0159
    • Tbilisi Heart and Vascular Clinic
  • Tbilisi, Georgia, 0112
    • Israeli-Georgian Medical Research Clinic Helsicore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years old
2. Office SBP ≥ 140 and < 180 mmHg on a stable dose of antihypertensive medication(s) for at least 30 days
3. Documented daytime systolic ABP ≥ 135 and < 170 mmHg

4. Waist circumference ≥ 102 cm (male) and ≥ 88 cm (female)

   Exclusion Criteria:

5. Renal artery anatomy on either side, ineligible for treatment including the following:

   1. Main renal artery diameter < 4.0 mm or > 7.0 mm
   2. Main renal artery length < 20.0 mm
   3. Only one functioning kidney
   4. Presence of abnormal kidney tumors
   5. Renal artery with aneurysm
   6. Pre-existing renal stent or history of renal artery angioplasty
   7. Fibromuscular disease of the renal arteries
   8. Presence of renal artery stenosis of any origin ≥ 30 %
   9. Individual lacks appropriate renal artery anatomy
6. Prior renal denervation procedure
7. Iliac/femoral artery stenosis precluding insertion of the iRF Catheter
8. Evidence of active infection within 7 days of the Index Procedure
9. Type 1 diabetes mellitus
10. Documented history of chronic active inflammatory bowel disorders such as Crohn disease or ulcerative colitis
11. eGFR < 45 mL/min per 1.73 m2
12. Brachial circumference ≥ 42 cm
13. Any history of cerebrovascular event (e.g., stroke, transient ischemic event, and cerebrovascular accident) within 6 months of patient consent
14. Myocardial infarction within 6 months of patient consent
15. Heart failure (New York Heart Association [NYHA] Class III-IV) at time of consent
16. Documented confirmed episode(s) of stable or unstable angina within 6 months of patient consent
17. Documented history of persistent or permanent atrial tachyarrhythmia
18. Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
19. Night shift workers
20. Chronic regular use (e.g., daily use) of NSAIDs for 6 months or greater. Aspirin therapy is allowed.
21. Active implantable medical device (e.g., ICD or CRT-D, neuromodulator/spinal stimulator, baroreflex stimulator)
22. Primary pulmonary HTN (> 60 mmHg pulmonary artery or right ventricular systolic pressure)
23. 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.)
24. Documented contraindication or allergy to contrast medium not amenable to treatment
25. Limited life expectancy of < 1 year at the discretion of the investigator
26. 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 requirements or whose participation may result in data analysis confounders (e.g., night shift workers)
27. Pregnant, nursing, or planning to become pregnant (documented negative pregnancy test result required documented within a maximum of 7 days before procedure for all women of childbearing potential)
28. Concurrent enrollment in any other investigational drug or device trial (participation in noninterventional registries is acceptable)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal denervation; Renal denervation with the iRF system	Device: iRF System Renal Denervation; The iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Major Adverse Events	Incidence of the following Major Adverse Events (MAEs); Death (all-cause); New onset end stage renal disease; Significant embolic events resulting in end-organ damage; Renal artery perforation or dissection requiring intervention; Hospital admission for hypertensive crisis not related to confirmed non-adherence with medications or protocol; New renal stenosis > 70 %	Index Procedure through 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic/Diastolic Blood Pressure - Average Automated Office Blood Pressure	Change from baseline in systolic/diastolic blood pressure as indicated by average automated office blood pressure	Time Frame: 30, 90, 180 and 365 days
Change in Systolic/Diastolic Blood Pressure - Ambulatory Blood Pressure Monitoring	Change from baseline in systolic/diastolic blood pressure as indicated by ambulatory blood pressure monitoring	Time Frame: 90, 180 and 365 days
Effects on renal function assessed with glomerular filtration rate	Change from baseline in renal function as indicated by eGFR	Time Frame: 30, 90, 180 and 365 days

Collaborators and Investigators

• Sponsor: Metavention

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2021
• Primary Completion (Actual): October 20, 2021
• Study Completion (Actual): October 13, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Renal Denervation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Hypertension; Metabolic Syndrome
• Other Study ID Numbers: 1880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes