Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-28 @ 7:18 PM
Study NCT ID:
NCT00969735
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2009-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation
Sponsor:
Hospital San Carlos, Madrid
Organization:
Study Overview
Official Title:
Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation (COR Trial)
Status:
COMPLETED
Status Verified Date:
2013-04
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:
COR
Brief Summary:
This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter versus the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.
Detailed Description:
Pulmonary vein (PV) isolation using a radiofrequency catheter is the most widespread technique for atrial fibrillation (AF) ablation. These procedures are difficult and time-consuming, because they require precise catheter manipulation and multiple radiofrequency applications. Thus, alternative techniques are being investigated to simplify the procedure. Recently, a cryoenergy balloon catheter has been developed for PV isolation (Arctic Front®, Cryocath Technologies). When this catheter is deployed at the PV antrum, it can create a circumferential lesion around the PV ostium by delivering a single cryoenergy application.
An implantable loop recorder for AF detection has been made available (Reveal XT®, Medtronic). It may help taking clinical decisions regarding anticoagulant and antiarrhythmic therapy and, at the same time, it may be a powerful tool to evaluate the efficacy of different therapeutic strategies.
This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter vs. the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.
An implantable loop recorder for AF detection has been made available (Reveal XT®, Medtronic). It may help taking clinical decisions regarding anticoagulant and antiarrhythmic therapy and, at the same time, it may be a powerful tool to evaluate the efficacy of different therapeutic strategies.
This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter vs. the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.
Study Oversight
Has Oversight DMC:
False
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?: