Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • RPD

    Device

    Renal Pelvic Denervation

  • Active hypertension medical therapy

    Drug

    Prespecified two medication regimen for control of hypertension

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: RPD armExperimental treatment 2 interventions
Group B: Sham armSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary effectiveness

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

Time frame
2 months post treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Verve Medical, Inc

Lead sponsor

RQM+

Collaborator

Dabl Ltd

Collaborator

Medical Labs Memphis - MLM

Collaborator

Source ClinicalTrials.gov
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