Sympathetic Mapping/ Ablation of Renal Nerves Trial - Hemodialysis
NCT04872114 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2021-05-04
Summary
To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I™ in patients on hemodialysis with pharmacotherapy and uncontrolled hypertension for at least 6 months, then after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days, office systolic blood pressure (BP) is still ≥ 150mmHg, ≤180mmHg.
Conditions
- Hypertension
- Hemodialysis
Interventions
- DEVICE
-
SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator
Radiofrequency ablation of renal arterial sympathetic nerves
Sponsors & Collaborators
-
SyMap Medical (Suzhou), Ltd.
collaborator INDUSTRY -
The Second Hospital of Nanjing Medical University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-01
- Primary Completion
- 2023-05-01
- Completion
- 2023-12-31
Countries
- China
Study Locations
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