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

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Hypertension
• Interventions: Device: iRF System Renal Denervation

• Registration Number: NCT04740723
• Lead Sponsor: Metavention

Brief 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.

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 Timeline

• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-05
• Study Start: 2021-02-06
• Primary Completion: 2021-10-20
• Study Completion: 2022-10-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal denervation	iRF System Renal Denervation	Renal denervation with the iRF system

Primary Outcome Measures

Name	Time	Method
Rate of Major Adverse Events	Index Procedure through 30 days	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 %

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Israeli-Georgian Medical Research Clinic Helsicore; 🇬🇪 Tbilisi, Georgia

Tbilisi Heart and Vascular Clinic; 🇬🇪 Tbilisi, Georgia