EARLY-MYO-AF Registry

Study Overview
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Brief Summary
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The purpose of this registry is to depict the myocardial function improvement in AF patients by integrated therapy and to assess the prognostic discrepancies of various intervention modalities. Information will be collected prospectively in about 5000 AF patients. Subjects will be followed for up to 3 years.

Detailed Description
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This is a prospective, single-centered, non-randomized, observational registry study of AF patients that undergo radio-frequency catheter ablation, left atrial appendage occlusion or surgical ablation. Information of other medication intervention and clinical outcomes are also prospectively collected in the database. This project will establish a prospective registry of 5000 AF patients with follow-ups of up to 3 years. The aim of the project will be as following: To investigate pathophysiological changes of both atrial and ventricular myocardial function in AF patients. To identify clinical indices (including baseline, comorbidities, medication or operational interventions) that are associated with adverse clinical outcomes. To spot potential therapeutical targets in the continuum of AF: from risk-factors elimination to mortality and disability prevalence reduciton.

Official Title
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EARLY-MYO-AF (EARLY Integrated Therapies on MYOcardial Function Improvements in Patients With Atrial Fibrillation) Registry

Conditions
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Atrial Fibrillation, Atrial Flutter

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible patients must be at least 18 years old at the time of enrollment. Patients who are clinically indicated catheter ablation or other interventions (LAAC or surgical maze procedure) for persistent or long standing persistent AF. Exclusion Criteria: Contraindication for anticoagulation therapy Another (non-AF) indication for long term anticoagulation Patients who have been enrolled as a respondent on other clinical studies Inability to attend scheduled, periodic office visits for follow-up Pregnancy Patient has a life expectancy of less than 6 months due to any condition.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | A composite of stroke/transient ischemic attack, thromboembolism and all-cause mortality. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding | A composite of events listed below: a)Bleeding resulting in a decrease in hemoglobin of ≥2 g/dL or over a 24-hour period b) Bleeding leading to a transfusion of 2 or more units of packed red blood cells c) Bleeding that occurs in a critical site (intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome or retroperitoneal) d. Bleeding that leads to death. | 3 years |