Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)

Atrial Fibrillation Clinical Trial

— AFICHE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03573869
• Other study ID #: 39052/21-12-17
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2018
• Source: G.Gennimatas General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 404
• Est. completion date: June 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• Heart Failure, Systolic

Intervention

Procedure:
• Cryoballoon ablation
Left atrial ablation using cryoballoon to achieve pulmonary vein isolation

Locations

Country	Name	City	State
Greece	Athens General Hospital "G. Gennimatas"	Athens

Sponsors (1)

Lead Sponsor	Collaborator
G.Gennimatas General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to exceed AG burden cut-off of 1%	The time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time)	Up to 2 years
Secondary	All-cause mortality or hospitalization for heart failure	Time to the composite of all-cause mortality and unplanned hospitalization for heart failure	Up to 2 years