Atrial FibrillationNCT04512222
EARLY-MYO-AF Registry
An observational study of Atrial Fibrillation and Atrial Flutter, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to 31 Dec 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AF patients undergo interventional or surgical procedures are eligible for this registry.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Xinhua Wang, Prof., 008602168383164, ttwwxh@126.com
About this study
Official title: EARLY-MYO-AF (EARLY Integrated Therapies on MYOcardial Function Improvements in Patients With Atrial Fibrillation) Registry
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:
- To investigate pathophysiological changes of both atrial and ventricular myocardial function in AF patients.
- To identify clinical indices (including baseline, comorbidities, medication or operational interventions) that are associated with adverse clinical outcomes.
- To spot potential therapeutical targets in the continuum of AF: from risk-factors elimination to mortality and disability prevalence reduciton.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
A composite of stroke/transient ischemic attack, thromboembolism and all-cause mortality.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Jan 2012
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinhua Wang, Prof., Study chair, Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512222
- Sponsor's protocol ID
- EARLY-MYO-AF
- Status last verified
- Jan 2012
- First submitted
- 11 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY-MYO-AF (EARLY Integrated Therapies on MYOcardial Function Improvements in Patients With Atrial Fibrillation) Registry
- ClinicalTrials.gov ID
- NCT04512222
- Acronym / sponsor ID
- EARLY-MYO-AF
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To investigate pathophysiological changes of both atrial and ventricular myocardial function in AF patients.
- To identify clinical indices (including baseline, comorbidities, medication or operational interventions) that are associated with adverse clinical outcomes.
- To spot potential therapeutical targets in the continuum of AF: from risk-factors elimination to mortality and disability prevalence reduciton.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AF patients undergo interventional or surgical procedures are eligible for this registry.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiovascular Events
Time frame: 3 years
A composite of stroke/transient ischemic attack, thromboembolism and all-cause mortality.
1 secondary outcome
Major bleeding
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Derived from this study: PubMed 34772362Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinhua Wang, Prof. study chair
Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingcong Kong, M.D. (008602168383164, avrilblanche373@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04512222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.