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Atrial Fibrillation (AF)AFMRNCT06630936

Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation

An observational study of Atrial Fibrillation (AF) and Atrial Functional Mitral Regurgitation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the improvement of mitral regurgitation after catheter ablation of atrial fibrillation or regular drug therapy in atrial fibrillation patients combined with atrial functional mitral regurgitation. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
500 participants
Where
1 siteChina
Study dates
27 Sep 2024to 30 Sep 2026
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Atrial fibrillation combined with atrial functional mitral regurgitation

Who may be able to join

  • Patients aged 18 to 80 years old;
  • Patients diagnosed with symptomatic paroxysmal atrial fibrillation (AF history \< 5 years)
  • Moderate to severe MR and normal LV ejection fraction (≥50%), LVEDD\<55 mm, and normal LV wall systolic function
  • Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol

Who cannot join

  • Atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible factors
  • Active endocarditis or active rheumatic heart disease, or degenerative mitral regurgitation due to endocarditis or rheumatic valvular heart disease
  • Moderate to severe mitral stenosis
  • Imaging examination shows left atrium or left atrial appendage thrombosis
  • Left ventricular ejection fraction less than 50%
  • Left atrial diameter more than 50mm
Show all 15Show fewer
  • Patients with previous left atrial appendage occlusion or left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure or repair (only applied for patients who need to ablation)
  • Patients who have implanted devices such as implantable cardioverter defibrillator(ICD), cardiac resynchronization therapy(CRT) or pacemaker
  • Previous metal artificial valve or valve repair device implantation (only applied for patients who need to ablation)
  • Presence of lateral thrombus, tumors or other abnormalities that interfere with vascular puncture or catheter operation (only applied for patients who need to ablation)
  • Anticoagulation contraindications, and history of blood clotting or bleeding abnormalities
  • Acute systemic infection
  • Female patients who are pregnant, lactating, or unable to use contraception during the study
  • Patients' life expectancy is less than 12 months
  • Abnormalities or diseases that the investigator believes should be excluded from the scope of enrollment in this study

Trial locations and contacts

1 site in 1 country.

Xianbao Liu, Dorctor contact

086-571-87784705

liuxb@zju.edu.cn

China1 site, 1 recruiting

  • Second Affiliated Hospital of Zhejiang University, School of Medicine

    Hangzhou, Zhejiang, 310000

    Xianbao Liu, Doctor, liuxb@zju.edu.cn

    Jian'an Wang, Doctor

    Recruiting

Other trials in China

About this study

Official title: Prospective Multi-Center Cohort Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation

To evaluate the improvement of mitral regurgitation after catheter ablation of atrial fibrillation or regular drug therapy in atrial fibrillation patients combined with atrial functional mitral regurgitation.

Read the detailed description

Atrial fibrillation results in the loss of the atria's normal contracting ability, leading to blood stasis within the left atrium and its subsequent enlargement. This condition can progress to cause dilation of the mitral annulus and mitral regurgitation-a phenomenon referred to as functional mitral regurgitation (FMR). Atrial functional mitral regurgitation (AFMR), triggered by the enlargement of the left atrium and remodeling of the mitral annulus, has increasingly become a focal point of research in recent times. Past studies have indicated that in patients who revert to and maintain sinus rhythm following catheter ablation for atrial fibrillation, there is a notable reduction in the size of the left atrium, the diameter of the mitral annulus, and the severity of mitral regurgitation. This suggests that patients with AFMR may derive significant benefits from the restoration of sinus rhythm. This investigation constitutes a prospective, multicenter cohort study. Eligible patients diagnosed with atrial fibrillation accompanied by atrial functional mitral regurgitation, who meet the inclusion criteria and do not fulfill the exclusion criteria, are being recruited. Depending on clinical judgment or patient preference, participants are assigned to receive either catheter ablation for atrial fibrillation or standard medical therapy, with the aim of assessing the impact of these different treatments on alleviating the degree of mitral regurgitation. The study aims to enroll 500 patients, with follow-up assessments scheduled at 3-month, 6-month, and 12-month intervals following enrollment.

Keywords
Atrial Fibrillation, Atrial Functional Mitral Regurgitation, catheter ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06630936
Study groupRoleWhat they receive
Catheter ablation cohortPatients who receive pulsed field ablation procedure
Drug treatment cohortPatients who receive regular drug therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in MR

    Defined as a decrease of ≥1 level in the severity stage at 1 year compared to baseline

    Measured: 3-month, 6-month, 12-month at follow-up

Secondary outcomes (10)

  1. Changes of MR in echocardiography examination

    Effective regurgitant area, regurgitant volume, and regurgitant fraction of the mitral valve from baseline

    Measured: 3-month, 6-month, 12-month at follow-up

  2. Changes of left ventricular function in echocardiography examination

    Left ventricular ejection fraction, end-systolic/end-diastolic volume, end-systolic/end-diastolic diameter, early diastolic mitral valve flow velocity E, mitral annular velocity e'at the septum and lateral wall, and E/e'

    Measured: 3-month, 6-month, 12-month at follow-up

  3. Changes of left atrial function in echocardiography examination

    Left atrial anteroposterior diameter and left atrial end-diastolic volume

    Measured: 3-month, 6-month, 12-month at follow-up

  4. Freedom from atrial arrhythmia recurrence

    Defined as ECG data (including surface ECG and 24-h Holter) during the efficacy evaluation period (blanking period to the end of the 12-month follow-up) without recording AF, AFL, or AT (arrhythmia monitoring device ≥ 30 s)

    Measured: 12-month at follow-up

  5. Burden of atrial arrhythmia

    Incidence and duration of atrial arrhythmias (atrial premature contractions, atrial tachycardia, atrial flutter, and atrial fibrillation)

    Measured: 12-month at follow-up

  6. Acute PVI success

    Immediate success rate of pulmonary vein isolation

    Measured: Immediately after cathete ablation procedure

  7. Procedure time

    Total procedure time, atrial fibrillation ablation time, radiofrequency energy time, and total fluoroscopy time

    Measured: Immediately after cathete ablation procedure

  8. Incidence rate of major adverse events

    death, myocardial infarction, pulmonary vein stenosis, diaphragmatic nerve palsy, systemic embolism, TIA/ischemic stroke, pericarditis, pericardial effusion/cardiac tamponade, atrioesophageal fistula, and severe vascular access complications

    Measured: 3-month, 6-month, 12-month at follow-up

  9. Incidence of heart failure-related events

    Including readmissions, stroke, and all-cause mortality

    Measured: 3-month, 6-month, 12-month at follow-up

  10. Changes in QoL

    KCCQ score and NYHA classification

    Measured: 3-month, 6-month, 12-month at follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start27 Sep 2024
  3. Primary completion31 May 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

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
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06630936
Sponsor's protocol ID
2024-0882
Acronym
AFMR
Status last verified
Sep 2024
First submitted
6 Oct 2024
Last updated
22 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation (AF) and Atrial Functional Mitral Regurgitation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 inclusion and 15 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 22 Nov 2024. 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 Xianbao Liu, Dorctor (086-571-87784705, liuxb@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in MR (time frame: 3-month, 6-month, 12-month at follow-up). 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 NCT06630936.

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 22 Nov 2024.

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