A Study of Non-Vascular Renal Denervation Using the Verve Medical Phoenix ™ System

NCT05440513 | Unknown FDA Device

• 1 other identifier: CP0002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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 potential benefit of renal denervation in hypertension, though these studies primarily denervate the kidneys by passing catheters through the arteries in the groin into the renal arteries. The TUSK study utilizes the Phoenix system to perform denervation by advancing the device (a thin electrode) through the urinary tract into the kidneys where radiofrequency energy is briefly applied to denervate the kidneys.

Conditions

Hypertension; Uncontrolled Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in mean daytime systolic blood pressure

  Mean daytime systolic blood pressure determined from ambulatory blood pressure monitoring

  Month 2

Secondary Outcomes (3)

• Change in mean 24-hour systolic blood pressure

  Month 2

• Change in automated office systolic blood pressure

  Month 2

• Safety of renal pelvic denervation

  Month 2

Other Outcomes (8)

• Effect on renal function

  Month 2

• Effect on index of renal function

  Month 2

• Effects on ABPM at month 6 (durability of effects)

  Through month 6

Study Arms (1)

Renal Pelvic Denervation

EXPERIMENTAL

Using the natural orifice of the urethra, the ureters are accessed (bilaterally and in sequence), to allow for an ablation device to be placed into the renal pelvis where RF energy is delivered to ablate renal nerves.

Device: Renal Pelvic Denervation (bilateral)

Interventions

Renal Pelvic Denervation (bilateral) DEVICE

Using the natural orifice of the urethra, the ureters are accessed (bilaterally and in sequence), to allow for an ablation device to be placed into the renal pelvis where RF energy is delivered to ablate renal nerves.

Also known as: renal nerve ablation, renal sympathectomy

Renal Pelvic Denervation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Verve Medical, Inc: lead
• Clinical Accelerator: collaborator
• Israeli-Georgian Medical Research Clinic Helsicore: collaborator
• Pineo Medical Ecosystem: collaborator

Study Sites (2)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Location

Pineo Medical Ecosystem

Tbilisi, Georgia

Location

Related Publications (2)

• Hering D, Hubbard BS, Weber MA, Heuser RR. Impact of Renal Pelvic Denervation on Systemic Hemodynamics and Neurohumoral Changes in a Porcine Model. Am J Nephrol. 2021;52(5):429-434. doi: 10.1159/000516186. Epub 2021 May 26.

  PMID: 34038910 BACKGROUND

• Hering D, Nikoleishvili D, Imedadze A, Dughashvili G, Klimiashvili Z, Bekaia E, Shengelia T, Kobalava M, Goguadze O, Emukhvari T, Druker V, Sackner-Bernstein J, Weber MA. Transurethral Renal Pelvic Denervation: A Feasibility Trial in Patients with Uncontrolled Hypertension. Hypertension. 2022 Dec;79(12):2787-2795. doi: 10.1161/HYPERTENSIONAHA.122.20048. Epub 2022 Oct 18.

  PMID: 36254733 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 1, 2022
• Study Start: January 25, 2021
• Primary Completion: February 5, 2022
• Study Completion: December 15, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GE (2)