Trans Ureteral Sympathectomy of the Kidney Study Using the Verve Medical Phoenix ™ System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Verve Medical, Inc
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change in mean daytime systolic blood pressure
- Last Updated
- 3 years ago
Overview
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.
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 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.
Investigators
Eligibility Criteria
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/1.73m
- •Type I diabetes mellitus.
Outcomes
Primary Outcomes
Change in mean daytime systolic blood pressure
Time Frame: Month 2
Mean daytime systolic blood pressure determined from ambulatory blood pressure monitoring
Secondary Outcomes
- 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)