Ignite Creation Date:
2024-07-17 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482840
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-26
Brief Title:
Safety and Efficacy of EasyCool Catheter
Sponsor:
MedFact Engineering GmbH
Organization:
MedFact Engineering GmbH
Study Overview
Official Title:
Safety and Efficacy of EasyCool Catheter - Prospective Monocentric Study
Status:
ACTIVE_NOT_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:
None
Brief Summary:
The goal of this observational study is to learn about risks and benefit of EasyCool Catheter for cardiovascular ablation in real-world patients suffering from cardiac arrythmias
The main questions it aims to answer are
will the cardiac arrythmia be removed and remain absent oc recurrent also 3 months after procedure
what are the adverse events at procedure after 3 and 6 months
All participants will receive cardiac ablation with EasyCool catheter
The main questions it aims to answer are
will the cardiac arrythmia be removed and remain absent oc recurrent also 3 months after procedure
what are the adverse events at procedure after 3 and 6 months
All participants will receive cardiac ablation with EasyCool catheter
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None