Actively Recruiting
Renal Pelvic Denervation Pilot Trial
Led by Verve Medical, Inc · Updated on 2026-01-08
60
Participants Needed
5
Research Sites
165 weeks
Total Duration
On this page
Sponsors
V
Verve Medical, Inc
Lead Sponsor
R
RQM+
Collaborating Sponsor
AI-Summary
What this Trial Is About
The RPD Pilot trial will evaluate the safety and effectiveness of Verve Medical's RPDTM renal denervation system for hypertensive patients with uncontrolled blood pressure despite use of two medications at a therapeutic dose. The novelty of the RPDTM system relates to its placement via natural orifice into the renal pelvis (bilaterally) for delivery of radiofrequency energy to ablate the nerves that pass through the outer wall of the renal pelvis, a technique referred to as renal pelvic denervation (RPD).
CONDITIONS
Official Title
Renal Pelvic Denervation Pilot Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently taking 2 anti-hypertensive medications: one targeting the renin-angiotensin system (ACE inhibitor, ARB, or renin inhibitor) and the second either a calcium channel blocker (amlodipine preferred) or a thiazide diuretic
- Stable anti-hypertensive medication regimen for at least 30 days
- Ambulatory mean daytime systolic blood pressure (SBP) of 135 mmHg or higher
- Ambulatory daytime SBP less than 170 mmHg and diastolic blood pressure (DBP) less than 105 mmHg
- Office SBP of 140 mmHg or higher and less than 180 mmHg
You will not qualify if you...
- History of non-compliance with medical care or treatments
- History of atrial fibrillation
- Pregnant, breastfeeding, or planning pregnancy
- Office SBP 180 mmHg or higher and DBP 110 mmHg or higher
- Untreated urinary tract infection
- Renal collecting system abnormalities preventing cystoscopy and pyelogram (e.g., duplicated collecting system)
- Pre-existing hydronephrosis, renal stones, or ectopic/pelvic/ptotic kidneys
- Receiving dialysis treatment
- Renal transplant recipient
- Only one kidney or dominant unilateral kidney function less than 35%
- Polycystic kidney disease
- Diabetes treated with SGLT2 inhibitors and/or GLP-1 agonists
- Persistent albuminuria (30-300 mg albumin/g creatinine)
- Focal sclerosing glomerulosclerosis
- Use of clonidine, guanfacine, or methyldopa
- Known secondary hypertension causes (adrenal disease, renovascular hypertension)
- Hyperaldosteronism or elevated aldosterone levels
- Glomerulonephritis, interstitial nephritis, or eGFR less than 45 ml/min/1.73m2
- Type I diabetes mellitus
- Stenotic valvular heart disease hazardous to blood pressure reduction
- Orthostatic hypotension episodes in past 6 months
- Recent myocardial infarction, unstable angina, or stroke (within 6 months)
- Symptomatic heart failure
- Echocardiographic evidence of certain cardiomyopathies or intracardiac mass
- Surgically correctable valvular heart disease
- Peripheral arterial disease with symptoms
- Any medical or psychiatric condition interfering with study participation
- Pulmonary hypertension, chronic oxygen therapy, or need for mechanical ventilation
- Untreated severe obstructive sleep apnea
- Medications affecting blood pressure off-target (e.g., NSAIDs, steroids)
- Uncorrected bleeding disorders
- Any condition affecting blood pressure or requiring interfering medications
- Life expectancy less than 24 months
- Night shift work
- Upper arm circumference greater than 20 inches
- Enrollment in another hypertension trial
- Prior device therapy for hypertension
- Recent recurrent kidney stones
- History of narcotic or opiate abuse or chronic pain on narcotics
- Active uroepithelial cancer
- Implanted urinary sphincter or penile prosthesis
- Planned medical procedures interfering with blood pressure measurement within 12 months
- Conditions interfering with blood pressure accuracy
- Vulnerable populations (e.g., incarcerated, cognitively challenged)
- Pre-existing urological abnormalities
- Urinary tract anomalies or renal diseases such as FSGS or diabetic nephropathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Panoramic Health / Southwest Kidney Institute, PLC
Surprise, Arizona, United States, 85374
Actively Recruiting
3
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
DaVita Clinical Research
Las Vegas, Nevada, United States, 89107
Actively Recruiting
Research Team
D
Dan Merz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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