Renal Pelvic Denervation Pilot Trial
ConditionUncontrolled Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorVerve Medical, Inc
About this trial
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
Qualifiers
Currently taking 2 anti-hypertensive medications (NOTE: no changes to medications allowed until after 2-month primary endpoint).
Stable antihypertensive medical regimen for at least 30 days.
Ambulatory mean daytime SBP ≥135 mmHg.
Ambulatory daytime SBP <170 and DBP <105 mmHg.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RPD
- Active hypertension medical therapy
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Verve Medical, Inc
Lead sponsor
RQM+
Collaborator
Dabl Ltd
Collaborator
Medical Labs Memphis - MLM
Collaborator
Source ClinicalTrials.gov