Evaluation of the Integrated Radio Frequency Denervation System for the Treatment of Hypertension

Hypertension Clinical Trial

— RADAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04740723
• Other study ID #: 1880
• Status: Completed
• Phase: N/A
• Start date: February 6, 2021
• Est. completion date: October 13, 2022

Study information

• Verified date: March 2023
• Source: Metavention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 13, 2022
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome

Intervention

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

Locations

Country	Name	City	State
Georgia	Israeli-Georgian Medical Research Clinic Helsicore	Tbilisi
Georgia	Tbilisi Heart and Vascular Clinic	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Metavention

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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