EARLY-MYO-AF Registry

NCT ID: NCT04512222

Last Updated: 2020-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2025-12-31

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:

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.

Conditions

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Atrial Fibrillation Atrial Flutter

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xinhua Wang, Prof.

Role: STUDY_CHAIR

Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

Locations

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Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lingcong Kong, M.D.

Role: CONTACT

008602168383164

Facility Contacts

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Xinhua Wang, Prof.

Role: primary

008602168383164

References

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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.

Reference Type DERIVED
PMID: 34772362 (View on PubMed)

Other Identifiers

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EARLY-MYO-AF

Identifier Type: -

Identifier Source: org_study_id

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