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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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This is a single-arm, open label, clinical outcome study to research the durability (success) of receiving a pulsed field ablation (PFA) per standard of care for treatment of atrial fibrillation during a subsequent procedure for the insertion of a left atrial appendage occlusion (LAAO) device. The reassessment of the initial ablation will be performed with or without additional ablation if needed.
Atrial fibrillation is a heart condition where the heart beats rapidly and/or irregularly. An ablation procedure is a form of treatment for atrial fibrillation to try to maintain or return the heart to a normal rhythm (called sinus rhythm). Ablation procedures can be done using heat (radiofrequency energy), cold (cryo energy), or electrical energy emitted by pulses (pulsed field ablation). Pulsed field ablation (PFA) is an invasive treatment procedure for which the doctor will deliver controlled energy through a PFA Catheter to destroy or scar the specific heart tissue causing the abnormal electrical signals. This scar helps to interrupt the abnormal electrical pathways and restore a normal heart rhythm. Ablation procedures are performed according to the standard of care.
The purpose of this study is to research the durability of receiving a PFA for the treatment of atrial fibrillation during a subsequent procedure performed at least 30 days after the initial ablation. The remapping procedure will utilize integrated electroanatomic mapping and intracardiac echocardiography to determine the index procedure technical success independent of arrhythmia recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm, open label - all enrolled subjects | Experimental | Remapping procedure with LAAO Implant with or without additional ablation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remapping Procedure | Device | Remapping procedure with LAAO Implant with or without additional ablation. |
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| Measure | Description | Time Frame |
|---|---|---|
| To prospectively assess durability of PFA ablation | Durability analysis will include % of patients with any PV reconnection, % of PVs reconnected, and % of patients with recovered conduction in the endocardial posterior wall (if posterior wall isolation performed at the index procedure). | From Index Ablation to Subsequent Re-mapping procedure with concomitant LAAO implant. The remapping procedure will occur approximately 30-180 days after the index ablation. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess arrhythmia-free survival in patients with confirmed durable PVI (+/-) posterior wall isolation | Patients demonstrating durable PVI (+/- posterior wall isolation) confirmed during remapping procedure will be monitored for arrhythmia recurrence. Arrhythmia recurrence will be evaluated based on 1-week extended Holter monitoring performed at 6 months and 12 months post ablation. | 6 months and 12 months post remapping procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Shore University Hospital | Recruiting | Bay Shore | New York | 11706 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Single-arm, open label
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| Assess clinical outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures. | Clinical outcomes following this novel prospective dual-procedure strategy will be analyzed, including assessment of clinical AT/AF recurrence and symptomatic arrhythmia recurrence. | From enrollment/index ablation to the 12month follow up post remapping procedure |
| Assess procedure related outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures. | Procedural related outcomes following this novel prospective dual-procedure strategy will be analyzed, including assessment of ischemic stroke/TIA, bleeding complications, hospitalizations, and death. | From enrollment/index ablation to the 12month follow up post remapping procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |