EARLY-MYO-AF Registry

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04512222
• Other study ID #: EARLY-MYO-AF
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2012
• Source: RenJi Hospital
• Contact: Lingcong Kong, M.D.
• Phone: 008602168383164
• Email: avrilblanche373[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Locations

Country	Name	City	State
China	Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Atrial fibrillation event	Documented Atrial fibrillation of more the 5 minutes duration.	3 years
Primary	Major Adverse Cardiovascular Events	A composite of stroke/transient ischemic attack, thromboembolism and all-cause mortality.	3 years
Secondary	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