Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension
NCT05934383 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-06-26
Summary
This prospective, single-arm, interventional study is designed to assess the short-term and long-term safety and efficacy of bilateral ultrasound renal sympathetic denervation (RDN) of the native kidneys in renal transplant patients with uncontrolled hypertension.
Objectives:
* To assess the short-term and long-term changes in ambulatory and office blood pressure (BP) following native kidney RDN in renal transplant patients
* To assess the long-term safety of native kidney RDN in renal transplant patients
* To assess the short-term and long-term change in antihypertensive drug prescriptions following native kidney RDN in renal transplant patients
* To assess the short-term and long-term change in adherence to antihypertensive drugs following native kidney RDN in renal transplant patients
Conditions
- Hypertension
- Kidney Transplantation
Interventions
- DEVICE
-
Paradise® ultrasound renal denervation system.
Bilateral renal sympathetic denervation of the native kidneys using the Paradise® ultrasound renal denervation system.
Sponsors & Collaborators
-
ReCor Medical, Inc.
collaborator INDUSTRY - lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-04
- Primary Completion
- 2026-01-31
- Completion
- 2030-09-30
Countries
- Netherlands
Study Locations
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