Hypertension, Metabolic Syndrome
Conditions
Keywords
Renal Denervation
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.
Interventions
DEVICEiRF 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
Sponsors
Metavention
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
The study is a prospective, single-arm, multi-center, non-randomized feasibility trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
Georgia
Outcome results
None listed