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

Hypertension Clinical Trial

— TUSK  

Official title:

Trans Ureteral Sympathectomy of the Kidney Study Using the Verve Medical Phoenix ™ System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05440513
• Other study ID #: CP0002
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: June 2022
• Source: Verve Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 on documented uncontrolled hypertension by 24-hour ambulatory blood pressure monitoring. Those qualifying will be expected to maintain their medical therapy without changes until after the primary effectiveness assessment two months later. Following baseline testing, patients will undergo renal pelvic denervation under anesthesia and remain in the hospital overnight. The denervation device is inserted through the urethra into each kidney and all devices are removed at the completion of the procedure. Radiofrequency energy is administered for a single 2-minute treatment period in each kidney. Follow up visits will extend to one year. Patients will complete medication logs along with repeat assessment of blood pressure in office and via 24-hour ambulatory blood pressure monitor. Follow up testing will also include imaging studies of the kidneys.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 15, 2022
• Est. primary completion date: February 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Key Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

Device:
• Renal Pelvic Denervation (bilateral)
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.

Locations

Country	Name	City	State
Georgia	Israeli-Georgian Medical Research Clinic Helsicore	Tbilisi
Georgia	Pineo Medical Ecosystem	Tbilisi

Sponsors (4)

Lead Sponsor	Collaborator
Verve Medical, Inc	Clinical Accelerator (CRO), Israeli-Georgian Medical Research Clinic Helsicore, Pineo Medical Ecosystem

Country where clinical trial is conducted

Georgia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect on renal function	Effects on serum creatinine	Month 2
Other	Effect on index of renal function	Effects on estimated glomerular filtration rate	Month 2
Other	Effects on ABPM at month 6 (durability of effects)	ABPM performed during follow-up	Through month 6
Other	Effects on ABPM month 12 (durability of effects)	ABPM performed during follow-up	Through month 12
Other	Effects on OBM at month 6 (durability of effects)	OBP performed during follow-up	Through month 6
Other	Effects on OBP at month 12 (durability of effects)	OBP performed during follow-up	Through month 12
Other	Safety of renal pelvic denervation	Number of subjects with serious adverse events, treatment-emergent adverse events and adverse events assessed, including evidence of acute kidney injury	Through month 6
Other	Safety of renal pelvic denervation	Number of subjects with serious adverse events, treatment-emergent adverse events and adverse events assessed, including evidence of acute kidney injury	Through month 12
Primary	Change in mean daytime systolic blood pressure	Mean daytime systolic blood pressure determined from ambulatory blood pressure monitoring	Month 2
Secondary	Change in mean 24-hour systolic blood pressure	Mean 24-hour systolic blood pressure determined from ambulatory blood pressure monitoring	Month 2
Secondary	Change in automated office systolic blood pressure	Automated office blood pressure measured after resting and in triplicate	Month 2
Secondary	Safety of renal pelvic denervation	Number of subjects with serious adverse events, treatment-emergent adverse events and adverse events assessed, including evidence for acute kidney injury and hypertension-related morbidity	Month 2