Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)

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


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.

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


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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note