Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation

NCT06630936 | Recruiting

• 1 other identifier: 2024-0882
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (AF); Atrial Functional Mitral Regurgitation

Keywords

Atrial Fibrillation; Atrial Functional Mitral Regurgitation; catheter ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Changes of MR in echocardiography examination

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

• Changes of left ventricular function in echocardiography examination

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

• Changes of left atrial function in echocardiography examination

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

• Freedom from atrial arrhythmia recurrence

  12-month at follow-up

• Burden of atrial arrhythmia

  12-month at follow-up

Study Arms (2)

Catheter ablation cohort

Patients who receive pulsed field ablation procedure

Drug treatment cohort

Patients who receive regular drug therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Atrial fibrillation combined with atrial functional mitral regurgitation

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianan Wang, Dorctor

  Second Affiliated Hospital of Zhejiang University, School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianbao Liu, Dorctor

CONTACT

086-571-87784705; liuxb@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 8, 2024
• Study Start: September 27, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)