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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoballoon ablation | Experimental | A 28-mm cryoballoon (Arctic Front Advanceâ„¢ 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. |
|
| Standard treatment | No Intervention | Standard treatment, including at least one rhythm control medication, on top of optimized rate control and HF treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoballoon ablation | Procedure | Left atrial ablation using cryoballoon to achieve pulmonary vein isolation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athens General Hospital "G. Gennimatas" | Recruiting | Athens | 11527 | Greece |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D054143 | Heart Failure, Systolic |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006333 | Heart Failure |