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ACTIVE NOT RECRUITING
NCT02761811
NA

Sympathetic Mapping/ Ablation of Renal Nerves Trial

Sponsor: SyMap Medical (Suzhou), Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I® and SYMPIONEER S1® Stimulator/ Generator in patients with essential hypertension for at least 6 months of the disease history and pharmacotherapy, however, their blood pressure still cannot be controlled, then after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days, office systolic blood pressure is still ≥ 150mmHg, ≤180mmHg.

Official title: A Prospective, Multicenter, Single Blind, Randomized and Sham Controlled Trial of Renal Sympathetic Denervation Using SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator for the Treatment of Hypertension (SMART Trial)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2016-06-30

Completion Date

2026-12-31

Last Updated

2023-08-02

Healthy Volunteers

No

Conditions

Interventions

DEVICE

SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator

Radiofrequency ablation of renal arterial sympathetic nerves

Locations (15)

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

The Second Afflicted Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Norman Bethune International Peace Hospital

Shijiazhuang, Hebei, China

Hebei General Hospital

Shijiazhuang, Hebei, China

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Nanjing First Hospital

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Shanghai Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Taiyuan Central Hospital

Taiyuan, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin First Center Hospital

Tianjin, Tianjin Municipality, China