ClinicalTrials.gg
RecruitingNCT04512222Updated Aug 13, 2020

EARLY-MYO-AF Registry

An observational study in Atrial Fibrillation and Atrial Flutter, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-13.

Sponsored by RenJi Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2022, 3 years 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2012; still recruiting 14 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Atrial Fibrillation
  • Atrial Flutter
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

AF patients undergo interventional or surgical procedures are eligible for this registry.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • 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 of less than 6 months due to any condition.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Major Adverse Cardiovascular Events

    A composite of stroke/transient ischemic attack, thromboembolism and all-cause mortality.

    Time frame: 3 years

Secondary outcomes

  1. 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.

    Time frame: 3 years

Other outcomes

  1. Atrial fibrillation event

    Documented Atrial fibrillation of more the 5 minutes duration.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
    Shanghai, Shanghai 200127, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 34772362 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2012 (actual). Primary completion is estimated for Dec 2022, 131 months after the start.

Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 131 months is above that.

Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2020
First posted
Aug 13, 2020
StartActual
Jan 1, 2012
Primary completionEst.
Dec 31, 2022
CompletionEst.
Dec 31, 2025
Last update
Aug 13, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04512222
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Aug 13, 2020
Start date
Jan 1, 2012
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 13, 2020

Study contacts

Lingcong Kong, M.D.
Contact
avrilblanche373@126.com
008602168383164
Xinhua Wang, Prof.
study chair · Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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