Renal Pelvic Denervation Pilot Trial

NCT07005050 | Recruiting DMC FDA Device

• 1 other identifier: CP0005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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

Uncontrolled Hypertension

Outcome Measures

Primary Outcomes (1)

• Primary effectiveness

  effects of the device/procedure on 24-hour blood pressure control in addition to use of 2 antihypertensive medications

  2 months post treatment

Study Arms (2)

RPD arm

EXPERIMENTAL

The Verve RPD™ system is used to perform renal pelvic denervation via the urinary collecting system for the treatment of hypertension. The system does so through the delivery of RF energy to the walls of the renal pelvis - delivered via natural orifice through the urinary tract. During the course of the study, patients will be on active medical therapy for their hypertension.

Device: RPD; Drug: Active hypertension medical therapy

Sham arm

SHAM COMPARATOR

Sham procedure will include all steps employed in the renal pelvis denervation with exception of activation of the RPD™ Device. Sham procedure includes advancing guidewire, cystoscope and sheath to position within the renal pelvis, then deploying the RPD™ Device into the renal pelvis (within each kidney), keeping the device in place for 2 minutes (within each kidney) to simulate activation, and then withdrawing the device and sheath. During the course of the study, sham patients will be on active medical therapy for their hypertension.

Drug: Active hypertension medical therapy

Interventions

RPD DEVICE

Renal Pelvic Denervation

RPD arm

Active hypertension medical therapy DRUG

Prespecified two medication regimen for control of hypertension

RPD arm; Sham arm

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently taking 2 anti-hypertensive medications (NOTE: no changes to medications allowed until after 2-month primary endpoint).
• \- As recommended in ACC/AHA 2017 Guideline,2 subjects are to be taking one anti-hypertensive antagonizing the renin-angiotensin system, including ACE inhibitor, ARB or renin inhibitor. Second drug should either be a calcium channel blocker (amlodipine preferred) or a thiazide diuretic.
• Stable antihypertensive medical regimen for at least 30 days.
• Ambulatory mean daytime SBP ≥135 mmHg.
• Ambulatory daytime SBP \<170 and DBP \<105 mmHg.
• Office systolic SBP ≥140 mmHg and \<180.

You may not qualify if:

• History of non-compliance with medical care or medical treatments.
• History of atrial fibrillation.
• Pregnant (verified with a urine or blood pregnancy test), breast-feeding, or planning to become pregnant. Note that all premenopausal women will be screened for pregnancy (see section 4.7.4).
• Office SBP ≥180 and DBP ≥110 mmHg.
• Untreated urinary tract infection.
• Renal collecting system is compromised, such that the subject cannot undergo routine cystoscopy and retrograde pyelogram, as exemplified by duplicated collecting system, i.e., two or more ipsilateral ureters.
• Pre-existing hydronephrosis, presence of renal calculi or ectopic, pelvic or ptotic kidney(s).
• Receiving dialysis treatment.
• Renal transplant recipient.
• Presence of only one kidney, or patients with dominant unilateral kidney function with one kidney split function less than 35%
• Polycystic kidney disease.
• Diabetes treated with SGLT2 inhibitor and/or GLP-1 agonist
• Persistent albuminuria (urine with 30-300 mg albumin/g creatinine)
• Focal sclerosing glomerulosclerosis.
• On any of the following medications: clonidine, guanfacine, or methyldopa.

Sponsors & Collaborators

• Verve Medical, Inc: lead
• RQM+: collaborator
• Dabl Ltd: collaborator
• Medical Labs Memphis - MLM: collaborator

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Panoramic Health / Southwest Kidney Institute, PLC

Surprise, Arizona, 85374, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

DaVita Clinical Research

Las Vegas, Nevada, 89107, United States

RECRUITING

Central Study Contacts

Dan Merz

CONTACT

6126699209; dmerz@verve-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study involves a hypertension study investigator and an operating endourologist. In the study, the hypertension investigator and their staff will be blinded to treatment through 12 months follow up. Equally, the patient will be blinded to the treatment. Masking will include isolation of medical records from the procedure and sensory isolation of the patient during procedure. All information will become available to the patient and hypertension team after the 12 months follow up.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is multi-center, randomized, double-blind and sham-controlled, with sham treated subjects undergoing a procedure that includes use of cystoscopic placement of a guidewire and sheath into one kidney and then the other, to mirror how subjects are treated with RPD.

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): March 2, 2029
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)