Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196170
Status:
UNKNOWN
Last Update Posted:
2008-03-19
First Post:
2005-09-12
Brief Title:
Randomized Study of Radiofrequency- vs Cryo-Ablation for Typical Isthmus-Dependent Atrial Flutter
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
Official Title:
Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs Cryo-Ablation in Typical Isthmus-Dependent Atrial Flutter
Status:
UNKNOWN
Status Verified Date:
2008-03
Last Known Status:
ACTIVE_NOT_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:
None
Brief Summary:
This randomized study compares two energy sources for the catheter based ablation of typical isthmus-dependent atrial flutter The standard radiofrequency RF ablation technique and the cryo-ablation technique regarding the acute and long term efficacy and safety
Detailed Description:
This randomized study compares two energy sources for the catheter based ablation of typical isthmus-dependent atrial flutter The standard radiofrequency RF ablation technique and the cryo-ablation technique The RF ablation of typical atrial flutter has become a standard approach with very high curing rates and low complication incidence However ablation with RF is painful since the underlying cardiac tissue heats up up to 70-80C inside the tissue and especially the target of ablation in typical atrial flutter the so-called cavo-tricuspid isthmus is a very pain-receptive area Cryo-ablation which destroys tissue by freezing it down to -80 to -90C is thought to be less painful or even painless with the same efficacy than RF ablation
The acute and long term 6 months follow-up non-invasive efficacy and safety is the combined endpoint
The acute and long term 6 months follow-up non-invasive efficacy and safety is the combined endpoint
Study Oversight
Has Oversight DMC:
None
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?:
None