| NCT ID | NCT07005050 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Verve Medical, Inc |
| Condition | Uncontrolled Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-30 |
| Primary Completion | 2026-10-30 |
Trial Parameters
Eligibility Fast-Check
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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).
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Stable antihypertensive medical regimen for at least 30 days. 3. Ambulatory mean daytime SBP ≥135 mmHg. 4. Ambulatory daytime SBP \<170 and DBP \<105 mmHg. 5. Office systolic SBP ≥140 mmHg and \<180. Exclusion Criteria: 1. History of non-compliance with medical care or medical treatments. 2. History of atrial fibrillation. 3. 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). 4. Office SBP ≥180 and DBP ≥110 mmHg.