Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)

  • STATUS
    Recruiting
  • End date
    Jun 1, 2022
  • participants needed
    404
  • sponsor
    G.Gennimatas General Hospital
Updated on 22 January 2021
electrocardiogram
ejection fraction
heart failure
electrocardiographic monitoring
paroxysmal atrial fibrillation
pulmonary vein isolation
atrial ablation

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.

Details
Condition Arrhythmia, Atrial Fibrillation, systolic heart failure, Atrial Fibrillation (Pediatric), Dysrhythmia
Treatment cryoballoon ablation
Clinical Study IdentifierNCT03573869
SponsorG.Gennimatas General Hospital
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

A minimum of at least two separate AF episodes recorded within the last 12 months, either on 12-lead rest ECG or on ambulatory ECG recordings (at least 5 minutes of AF on Holter recordings will be required)
LVEF <40% on sinus rhythm
symptoms consistent with heart failure (New York Heart Association II or higher) despite rate control treatment
age >21 years old

Exclusion Criteria

previous left atrial ablation
left atrial diameter >28 mm/m2 BSA on TTE (parasternal long axis view)
strong clinical suspicion that reduced LVEF is primarily due to tachycardiomyopathy
pre-existing device (ICD or CRT) without AF detection algorithms and/or (for CRT devices) diagnostics of effective biventricular pacing
known primary electrical heart disease (e.g. Brugada syndrome)
presence of thrombus in a heart chamber
presence of prosthetic valve at any position
moderate/severe valvular heart disease
active infectious disease or malignancy
moderate or severe hepatic impairment (Child-Pugh class B or C)
severe renal failure (estimated glomerular filtration rate <20 ml/min/1.73 m2)
inability or unwillingness to adhere to standard treatment or to provide consent
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