Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192972
Status:
COMPLETED
Last Update Posted:
2005-12-22
First Post:
2005-09-12
Brief Title:
A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation LASso Vs CARto
Status:
COMPLETED
Status Verified Date:
2003-11
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:
Both segmental ostial and circumferential extra-ostial pulmonary vein PV isolation have been proven effective in the treatment of atrial fibrillation
In this study patients with symptomatic paroxystic or persistent AF were randomised to one of the above mentioned ablation methods The primary endpoints were recurrent AF and recurrence of left atrium-PV conduction
In this study patients with symptomatic paroxystic or persistent AF were randomised to one of the above mentioned ablation methods The primary endpoints were recurrent AF and recurrence of left atrium-PV conduction
Detailed Description:
Both segmental ostial and circumferential extra-ostial pulmonary vein PV isolation have been proven effective in the treatment of atrial fibrillation
In this study with symptomativ paroxystic or persistent AF were randomised to one of the above mentioned ablation methods Each patient was allowed a maximum of two ablation procedures Holter monitoring for 14-days periods will be performed at 3 months after ablation The patiens are seen at out-patient visits at 1 3 6 9 and 12 months after the ablation procedure
Primary endpoints were recurrent AF and recurrence of left atrium-PV conduction
Secondary endpoints were
safety
resumption of LA-PV conduction
alterations in neurohormones
socio-economics aspectscost effectiveness
changes in inflammatory markers
quality of life
alterations in signal averaged P wawe signals
evaluation of the predictive value of these variables to predict recurrence of AF
In this study with symptomativ paroxystic or persistent AF were randomised to one of the above mentioned ablation methods Each patient was allowed a maximum of two ablation procedures Holter monitoring for 14-days periods will be performed at 3 months after ablation The patiens are seen at out-patient visits at 1 3 6 9 and 12 months after the ablation procedure
Primary endpoints were recurrent AF and recurrence of left atrium-PV conduction
Secondary endpoints were
safety
resumption of LA-PV conduction
alterations in neurohormones
socio-economics aspectscost effectiveness
changes in inflammatory markers
quality of life
alterations in signal averaged P wawe signals
evaluation of the predictive value of these variables to predict recurrence of AF
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