Clinical trial NCT04512222: EARLY-MYO-AF Registry
Official title: EARLY-MYO-AF (EARLY Integrated Therapies on MYOcardial Function Improvements in Patients With Atrial Fibrillation) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Atrial Flutter
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AF patients undergo interventional or surgical procedures are eligible for this registry.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 3 years
Secondary outcomes:
measure: Major bleeding
timeFrame: 3 years
Other outcomes:
measure: Atrial fibrillation event
timeFrame: 3 years
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
name: Xinhua Wang, Prof.
role: STUDY_CHAIR
References:
citation: Wang XH, Kong LC, Shuang T, Li Z, Pu J. Macro-reentrant atrial tachycardia after tricuspid or mitral valve surgery: is there difference in electrophysiological characteristics and effectiveness of catheter ablation? BMC Cardiovasc Disord. 2021 Nov 12;21(1):538. doi: 10.1186/s12872-021-02368-w.