Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-04 @ 4:51 PM
Study NCT ID:
NCT03573869
Status:
UNKNOWN
Last Update Posted:
2018-07-09
First Post:
2018-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)
Sponsor:
G.Gennimatas General Hospital
Organization:
Study Overview
Official Title:
Effect of Cryoballoon Pulmonary Vein Isolation on Atrial Fibrillation Burden and Clinical Endpoints in Patients With Heart Failure With Impaired Left Ventricular Systolic Function
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
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:
AFICHE
Brief Summary:
In this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon ablation (left atrial balloon cryoablation for pulmonary vein isolation). All patients with either have an ICD or CRT-D/P device implanted or an implantable electrocardiographic monitoring device. The primary study endpoint will be the time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time).16 This AF burden corresponds to 7.2 hours per month.
A powered secondary endpoint will be the time to the composite of all-cause mortality and unplanned hospitalization for heart failure.
A powered secondary endpoint will be the time to the composite of all-cause mortality and unplanned hospitalization for heart failure.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: