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

March 13, 2023 updated by: Metavention

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Major Adverse Events
Time Frame: 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 %
Index Procedure through 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Systolic/Diastolic Blood Pressure - Average Automated Office Blood Pressure
Time Frame: Time Frame: 30, 90, 180 and 365 days
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
Time Frame: Time Frame: 90, 180 and 365 days
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
Time Frame: Time Frame: 30, 90, 180 and 365 days
Change from baseline in renal function as indicated by eGFR
Time Frame: 30, 90, 180 and 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Metavention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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