Status:
UNKNOWN
A Study of Non-Vascular Renal Denervation Using the Verve Medical Phoenix ™ System
Lead Sponsor:
Verve Medical, Inc
Collaborating Sponsors:
Clinical Accelerator
Israeli-Georgian Medical Research Clinic Helsicore
Conditions:
Hypertension
Uncontrolled Hypertension
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The aim of the study is to assess the safety and effectiveness of a novel device for renal denervation to lower blood pressure in people with uncontrolled hypertension. Prior studies demonstrate the p...
Detailed Description
Up to 20 patients with uncontrolled hypertension will be treated with the PhoenixTM renal pelvic denervation system, whether or not receiving background medical therapy. Qualification will be based o...
Eligibility Criteria
Inclusion
- Key
- Off-med group: (1) Ambulatory mean daytime SBP ≥140 mmHg in patients never treated for hypertension or after being taken off anti-hypertension medications for 4 weeks before ambulatory blood pressure assessment. (2) Ambulatory daytime SBP and DBP less than 170/105 mmHg. (3) Subjects will not be on ANY anti-hypertension medications or will be willing to discontinue current anti-hypertension medications.
- On-med group: (1) Subjects who are currently taking 1, 2, or 3 anti-hypertensive medications. (2) Ambulatory mean daytime SBP ≥135 mmHg. (3) Ambulatory daytime SBP and DBP less than 170/105 mmHg.
Exclusion
- Females who are either pregnant or breastfeeding.
- Office SBP or DBP ≥180/110 mmHg.
- Untreated urinary tract infection.
- Renal collecting system is compromised, and subject cannot undergo routine cystoscopy and retrograde pyelogram.
- Dialysis patients.
- Renal transplant patients.
- Subjects on the following medications, clonidine, guanfacine and methyldopa.
- Known secondary causes of hypertension such as adrenal disease, renal artery stenosis, renovascular hypertension.
- Subjects with glomerulonephritis or interstitial nephritis or eGFR \< 45 ml/min/1.73m2.
- Type I diabetes mellitus.
- Stenotic valvular heart disease for which reduction of blood pressure would be hazardous.
- Subjects with orthostatic hypotension.
- Myocardial infarction, unstable angina, or stroke in the prior 6 months.
- Any medical condition (including psychiatric disease) that would interfere with conducting the study or would not be in the best interest of the subject.
- Inability of the subject to provide informed consent.
- Subjects with sleep apnea.
- Patients taking any drugs that affect blood pressure through off target effects
- Patients with any clinical condition that can affect blood pressure or require the use of drugs that can affect blood pressure. e.g. NSAIDs, steroids, cold remedies.
- Patients who may require any procedure that can affect blood pressure.
- Patients who work a night shift.
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05440513
Start Date
January 25 2021
End Date
December 15 2022
Last Update
July 6 2022
Active Locations (2)
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1
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia
2
Pineo Medical Ecosystem
Tbilisi, Georgia