Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT02920034
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2016-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Comparison of Ultrasound Versus Radiofrequency Denervation in Patients With Therapy Resistant Hypertension
Sponsor:
Heart Center Leipzig - University Hospital
Organization:
Study Overview
Official Title:
A Randomized Comparison of Ultrasound Based Versus Radiofrequency Based Catheter Ablation Techniques in Patients With Therapy Resistant Arterial Hypertension With Large Renal Arteries
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADIOSOUND
Brief Summary:
Prospective, randomized trial to assess the effectiveness of different renal sympathetic denervation methods (radiofrequency main vs. branches + main vs. ultrasound based) in a cohort of patients with therapy refractory arterial hypertension and large renal arteries
Detailed Description:
The aim of this trial is a prospective, randomized comparison of three different techniques for catheter based renal sympathetic denervation. Patients with larger (\>5.5 mm) renal arteries are randomized to a treatment with a radiofrequency based catheter of the main renal artery, the main renal artery, its side-branches and accessories or an ultrasound-based denervation of the main renal artery only. The primary endpoint is the change in daytime blood pressure acquired in ambulatory blood pressure measurement at 3 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: