Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT01504451
Status:
UNKNOWN
Last Update Posted:
2014-06-26
First Post:
2011-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study
Sponsor:
Neil Sulke
Organization:
Study Overview
Official Title:
Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2
Status:
UNKNOWN
Status Verified Date:
2014-06
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:
LAAPITUP 2
Brief Summary:
This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.
Detailed Description:
A target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. Each participant will have an implantable loop recorder (ILR) prior to ablation in order to assess AF burden. After ablation, each participant will be followed up for a year. The ILR will be used to assess reduction in AF burden.
Study Oversight
Has Oversight DMC:
True
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?: