EARLY-MYO-AF Registry

Recruiting

• Conditions: Atrial Fibrillation; Atrial Flutter

• Registration Number: NCT04512222
• Lead Sponsor: RenJi Hospital

Brief Summary

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

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:

1. To investigate pathophysiological changes of both atrial and ventricular myocardial function in AF patients.

2. To identify clinical indices (including baseline, comorbidities, medication or operational interventions) that are associated with adverse clinical outcomes.

3. To spot potential therapeutical targets in the continuum of AF: from risk-factors elimination to mortality and disability prevalence reduciton.

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01-01
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Study First Posted: 2020-08-13
• Last Update Posted: 2020-08-13
• Primary Completion: 2022-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	3 years	A composite of stroke/transient ischemic attack, thromboembolism and all-cause mortality.

Secondary Outcome Measures

Name	Time	Method
Major bleeding	3 years	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.

Trial Locations

Locations (1)

Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China