Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05904548
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-04-13
Brief Title:
Atrial Flutter Ablation in the iCMR
Sponsor:
Imricor Medical Systems
Organization:
Imricor Medical Systems
Study Overview
Official Title:
Vision-MR Ablation Catheter 20 for Treatment of Type I Atrial Flutter
Status:
RECRUITING
Status Verified Date:
2024-06
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:
VISABL-AFL
Brief Summary:
The VISABL-AFL clinical investigation is a prospective single-arm multi-center interventional Investigational Device Exemption IDE trial The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency RF ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 20 in the iCMR environment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None