Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cryoballoon ablation A 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12F FlexCath steerable sheath (Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time. |
Procedure: Cryoballoon ablation
Left atrial ablation using cryoballoon to achieve pulmonary vein isolation
|
| No Intervention: Standard treatment Standard treatment, including at least one rhythm control medication, on top of optimized rate control and HF treatment |
Outcome Measures
Primary Outcome Measures
- Time to exceed AG burden cut-off of 1% [Up to 2 years]
The time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time)
Secondary Outcome Measures
- All-cause mortality or hospitalization for heart failure [Up to 2 years]
Time to the composite of all-cause mortality and unplanned hospitalization for heart failure
Eligibility Criteria
Criteria
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),
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LVEF <40% on sinus rhythm,
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symptoms consistent with heart failure (New York Heart Association II or higher) despite rate control treatment,
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age >21 years old.
Exclusion criteria:
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previous left atrial ablation,
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left atrial diameter >28 mm/m2 BSA on TTE (parasternal long axis view),
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strong clinical suspicion that reduced LVEF is primarily due to tachycardiomyopathy,
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pre-existing device (ICD or CRT) without AF detection algorithms and/or (for CRT devices) diagnostics of effective biventricular pacing,
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known primary electrical heart disease (e.g. Brugada syndrome),
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presence of thrombus in a heart chamber,
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presence of prosthetic valve at any position,
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moderate/severe valvular heart disease,
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active infectious disease or malignancy,
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moderate or severe hepatic impairment (Child-Pugh class B or C),
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severe renal failure (estimated glomerular filtration rate <20 ml/min/1.73 m2),
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inability or unwillingness to adhere to standard treatment or to provide consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Athens General Hospital "G. Gennimatas" | Athens | Greece | 11527 |
Sponsors and Collaborators
- G.Gennimatas General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 39052/21-12-17