FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension
NCT05590871 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2024-11-20
Summary
To verify the safety and effectiveness of the renal artery radiofrequency ablation system under the guidance of the three-dimensional cardiac electrophysiological mapping system in the renal denervation of essential hypertension.
Conditions
Interventions
- DEVICE
-
FlashPoint renal denervation system
Radio-frequency ablation of renal arterial sympathetic nerves
- OTHER
-
Sham
After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Sponsors & Collaborators
-
Shanghai Hongdian Medical CO., LTD
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-31
- Primary Completion
- 2025-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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