Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-03-03 @ 4:02 PM
Study NCT ID:
NCT01520506
Status:
COMPLETED
Last Update Posted:
2019-03-01
First Post:
2012-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rapid Renal Sympathetic Denervation for Resistant Hypertension
Sponsor:
Medtronic Endovascular
Organization:
Study Overview
Official Title:
Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System
Status:
COMPLETED
Status Verified Date:
2019-02
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:
RAPID
Brief Summary:
The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.
Detailed Description:
Unique to the OneShot™ ablation system is the ability to deliver the desired helical treatment pattern for optimal Renal Denervation (RDN) with a single balloon based-treatment, eliminating user variance inherent in the currently available point-by-point approach. In addition, technological improvements have been incorporated. The OneShot™ RF generator has a touchscreen, user friendly interface; catheter advancement is made safer with the use of a guidewire; two radiopaque markers on the catheter enable more precise device positioning; and the irrigated catheter tip reduces the risk of overheating and clot formation during RF delivery. By offering a more reliable single treatment approach, coupled with enhanced ease-of use and reduced procedure times, this technology has the potential to significantly expand clinical adoption of catheter-based renal sympathetic denervation.
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?: