Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-31 @ 12:52 AM
Study NCT ID:
NCT04845750
Status:
UNKNOWN
Last Update Posted:
2022-07-21
First Post:
2021-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The RODEO Micro Mapping Catheter in Cryoablation Procedures
Sponsor:
afreeze GmbH
Organization:
Study Overview
Official Title:
The RODEO Micro Mapping Catheter in Cryoablation Procedures - A Feasibility Study
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
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:
RODEO-MaPS
Brief Summary:
This clinical investigation evaluates the feasibility of the Rodeo Micro Mapping Catheter in combination with cryoablation ssystem (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted).
Further aims of this study are the evaluation of safety of the device and average procedure and fluoroscopy times.
Further aims of this study are the evaluation of safety of the device and average procedure and fluoroscopy times.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: