NCT03573869

Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 404 (estimated)
• Sponsor: G.Gennimatas General Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Heart Failure, Systolic

Interventions

Type	Name	Description
PROCEDURE	Cryoballoon ablation	Left atrial ablation using cryoballoon to achieve pulmonary vein isolation

Timeline

• Start date: 2018-06-01
• Primary completion: 2021-12-31
• Completion: 2022-06-01
• First posted: 2018-06-29
• Last updated: 2018-07-09

Locations

1 site across 1 country: Greece