Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation (AFMR)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF); Atrial Functional Mitral Regurgitation

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Xianbao Liu, Dorctor; Phone Number: 086-571-87784705; Email: liuxb@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Second Affiliated Hospital of Zhejiang University, School of Medicine
      • Contact: Xianbao Liu, Doctor; Email: liuxb@zju.edu.cn
      • Contact: Jian'an Wang, Doctor
      • Contact: Xianbao Liu, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Atrial fibrillation combined with atrial functional mitral regurgitation

Description

Inclusion Criteria:

1. Patients aged 18 to 80 years old;
2. Patients diagnosed with symptomatic paroxysmal atrial fibrillation (AF history < 5 years)
3. Moderate to severe MR and normal LV ejection fraction (≥50%), LVEDD<55 mm, and normal LV wall systolic function
4. 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

Exclusion Criteria:

1. Atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible factors
2. Active endocarditis or active rheumatic heart disease, or degenerative mitral regurgitation due to endocarditis or rheumatic valvular heart disease
3. Moderate to severe mitral stenosis
4. Imaging examination shows left atrium or left atrial appendage thrombosis
5. Left ventricular ejection fraction less than 50%
6. Left atrial diameter more than 50mm
7. 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)
8. Patients who have implanted devices such as implantable cardioverter defibrillator(ICD), cardiac resynchronization therapy(CRT) or pacemaker
9. Previous metal artificial valve or valve repair device implantation (only applied for patients who need to ablation)
10. Presence of lateral thrombus, tumors or other abnormalities that interfere with vascular puncture or catheter operation (only applied for patients who need to ablation)
11. Anticoagulation contraindications, and history of blood clotting or bleeding abnormalities
12. Acute systemic infection
13. Female patients who are pregnant, lactating, or unable to use contraception during the study
14. Patients' life expectancy is less than 12 months
15. Abnormalities or diseases that the investigator believes should be excluded from the scope of enrollment in this study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Catheter ablation cohort; Patients who receive pulsed field ablation procedure
Drug treatment cohort; Patients who receive regular drug therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in MR	Defined as a decrease of ≥1 level in the severity stage at 1 year compared to baseline	3-month, 6-month, 12-month at follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of MR in echocardiography examination	Effective regurgitant area, regurgitant volume, and regurgitant fraction of the mitral valve from baseline	3-month, 6-month, 12-month at follow-up
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'	3-month, 6-month, 12-month at follow-up
Changes of left atrial function in echocardiography examination	Left atrial anteroposterior diameter and left atrial end-diastolic volume	3-month, 6-month, 12-month at follow-up
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)	12-month at follow-up
Burden of atrial arrhythmia	Incidence and duration of atrial arrhythmias (atrial premature contractions, atrial tachycardia, atrial flutter, and atrial fibrillation)	12-month at follow-up
Acute PVI success	Immediate success rate of pulmonary vein isolation	Immediately after cathete ablation procedure
Procedure time	Total procedure time, atrial fibrillation ablation time, radiofrequency energy time, and total fluoroscopy time	Immediately after cathete ablation procedure
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	3-month, 6-month, 12-month at follow-up
Incidence of heart failure-related events	Including readmissions, stroke, and all-cause mortality	3-month, 6-month, 12-month at follow-up
Changes in QoL	KCCQ score and NYHA classification	3-month, 6-month, 12-month at follow-up

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Jianan Wang, Dorctor, Second Affiliated Hospital of Zhejiang University, School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: October 6, 2024
• First Submitted That Met QC Criteria: October 6, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; catheter ablation; Atrial Functional Mitral Regurgitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Valve Diseases; Atrial Fibrillation; Mitral Valve Insufficiency
• Other Study ID Numbers: 2024-0882

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No