This small-scale, proof-of-concept pilot study aims to obtain preliminary evidence of msRDN procedural safety, feasibility, and short-term efficacy in patients with hypertension without medication therapy, to adequately plan an appropriate pivotal study.
This is a prospective, multicenter, single-arm, exploratory study enrolling 15 subjects across approximately four sites with a 6-month follow-up period. Subjects are patients with uncontrolled hypertension who receive 1-2 antihypertensive medications and have completed a minimum two-week medication wash-out period prior to enrollment, or patients with uncontrolled hypertension without medication therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Radiofrequency ablation of renal arterial sympathetic nerves
Shanghai Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Change in daytime ASBP
mean change in average daytime ASBP from baseline to 2 months post-procedure.
Time frame: From baseline to 2 months after RDN
Change in office SBP
Change in Office Systolic BP from baseline to 1 month,2 months,3 months and 6 months post-procedure;
Time frame: From baseline to 1, 2, 3 and 6 months after RDN
Change in average 24-hr/Night-time Ambulatory BP(Systolic and Diastolic)
change in Average 24-hr/Night-time Ambulatory BP(Systolic and Diastolic) from baseline to 2 months and daytime ambulatory Diastolic BP from baseline to 2 months post procedure
Time frame: From baseline to 2 months after RDN (for both 24-hr and night-time SBP/DBP); From baseline to 2 months after RDN (for daytime DBP)
Change in 24-hr Ambulatory BP
Change in 24-hr Ambulatory BP from baseline to 6 months post-procedure
Time frame: From baseline to 6 months after RDN
Change in anti-hypertensive Drugs
Change in anti-hypertensive Drugs form baseline to 1 month、2 months、3 months and 6 months post-procedure;
Time frame: From baseline to 1, 2, 3 and 6 months after RDN
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.