HypertensionRADARNCT04740723
Evaluation of the Integrated Radio Frequency Denervation System for the Treatment of Hypertension
A study testing iRF System Renal Denervation in people with Hypertension and Metabolic Syndrome, run by Metavention at 2 sites in Georgia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Metabolic Syndrome
- What is being tested?
- iRF System Renal Denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesGeorgia
- Study dates
- 6 Feb 2021to 13 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
- eGFR < 45 mL/min per 1.73 m2
- Brachial circumference ≥ 42 cm
- Any history of cerebrovascular event (e.g., stroke, transient ischemic event, and cerebrovascular accident) within 6 months of patient consent
- Myocardial infarction within 6 months of patient consent
- Heart failure (New York Heart Association [NYHA] Class III-IV) at time of consent
- Documented confirmed episode(s) of stable or unstable angina within 6 months of patient consent
- Documented history of persistent or permanent atrial tachyarrhythmia
- Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- Night shift workers
- Chronic regular use (e.g., daily use) of NSAIDs for 6 months or greater. Aspirin therapy is allowed.
- Active implantable medical device (e.g., ICD or CRT-D, neuromodulator/spinal stimulator, baroreflex stimulator)
- Primary pulmonary HTN (> 60 mmHg pulmonary artery or right ventricular systolic pressure)
- 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.)
- Documented contraindication or allergy to contrast medium not amenable to treatment
- Limited life expectancy of < 1 year at the discretion of the investigator
- 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)
- 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)
- Concurrent enrollment in any other investigational drug or device trial (participation in noninterventional registries is acceptable)
Trial locations and contacts
2 sites in 1 country.
Georgia2 sites
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, 0112
Tbilisi Heart and Vascular Clinic
Tbilisi, 0159
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Metabolic Syndrome
- Being tested
- iRF System Renal Denervation
- Keywords
- Renal Denervation
- Medical subject headings
- Hypertension, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iRF System Renal DenervationDevice
The iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the artery
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation | Experimental | Renal denervation with the iRF system Receives: Device: iRF System Renal Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %
Measured: Index Procedure through 30 days
Secondary outcomes (3)
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
Measured: Time Frame: 30, 90, 180 and 365 days
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
Measured: Time Frame: 90, 180 and 365 days
Effects on renal function assessed with glomerular filtration rate
Change from baseline in renal function as indicated by eGFR
Measured: Time Frame: 30, 90, 180 and 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start6 Feb 2021
- Primary completion20 Oct 2021
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a prospective, single-arm, multi-center, non-randomized feasibility trial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metavention
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740723
- Sponsor's protocol ID
- 1880
- Acronym
- RADAR
- Status last verified
- Mar 2023
- First submitted
- 25 Jan 2021
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Renal Artery Denervation Feasibility Study of the MetAvention Integrated Radio Frequency Denervation System for the Treatment of Hypertension
- ClinicalTrials.gov ID
- NCT04740723
- Acronym / sponsor ID
- RADAR / 1880
- Conditions
- Hypertension, Metabolic Syndrome
- Keywords
- Renal Denervation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- MetaventionIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2021 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a prospective, single-arm, multi-center, non-randomized feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | Experimental | Device: iRF System Renal DenervationRenal denervation with the iRF system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (33 listed)
- Renal artery anatomy on either side, ineligible for treatment including the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iRF System Renal DenervationThe iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the artery | Device | Renal denervation |
Primary outcome
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 %
3 secondary outcomes
Change in Systolic/Diastolic Blood Pressure - Average Automated Office Blood Pressure
Time frame: 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
Effects on renal function assessed with glomerular filtration rate
Time frame: Time Frame: 30, 90, 180 and 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iRF System Renal Denervation in people with Hypertension and Metabolic Syndrome, run by Metavention at 2 sites in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Major Adverse Events (time frame: Index Procedure through 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.