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

NCT04740723 | Completed

• 1 other identifier: 1880
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension; Metabolic Syndrome

Keywords

Renal Denervation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Systolic/Diastolic Blood Pressure - Average Automated Office Blood Pressure

  Time Frame: 30, 90, 180 and 365 days

• Change in Systolic/Diastolic Blood Pressure - Ambulatory Blood Pressure Monitoring

  Time Frame: 90, 180 and 365 days

• Effects on renal function assessed with glomerular filtration rate

  Time Frame: 30, 90, 180 and 365 days

Study Arms (1)

Renal denervation

EXPERIMENTAL

Renal denervation with the iRF system

Device: iRF System Renal Denervation

Interventions

iRF System Renal Denervation DEVICE

The iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the artery

Renal denervation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 80 years old
• Office SBP ≥ 140 and \< 180 mmHg on a stable dose of antihypertensive medication(s) for at least 30 days
• Documented daytime systolic ABP ≥ 135 and \< 170 mmHg
• Waist circumference ≥ 102 cm (male) and ≥ 88 cm (female)

You may not qualify if:

• Renal artery anatomy on either side, ineligible for treatment including the following:
• Main renal artery diameter \< 4.0 mm or \> 7.0 mm
• Main renal artery length \< 20.0 mm
• Only one functioning kidney
• Presence of abnormal kidney tumors
• Renal artery with aneurysm
• Pre-existing renal stent or history of renal artery angioplasty
• Fibromuscular disease of the renal arteries
• Presence of renal artery stenosis of any origin ≥ 30 %
• Individual lacks appropriate renal artery anatomy
• Prior renal denervation procedure
• Iliac/femoral artery stenosis precluding insertion of the iRF Catheter
• Evidence of active infection within 7 days of the Index Procedure
• Type 1 diabetes mellitus
• Documented history of chronic active inflammatory bowel disorders such as Crohn disease or ulcerative colitis

Sponsors & Collaborators

• Metavention: lead

Study Sites (2)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

Tbilisi Heart and Vascular Clinic

Tbilisi, 0159, Georgia

Location

MeSH Terms

Conditions

Hypertension; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a prospective, single-arm, multi-center, non-randomized feasibility trial

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 5, 2021
• Study Start: February 6, 2021
• Primary Completion: October 20, 2021
• Study Completion: October 13, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

GE (2)