Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation
Primary Purpose
Persistent Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bi-atrial ablation
Left atrial ablation
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Rheumatic mitral valve disease, Surgical ablation, Mitral valve surgery
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Diagnosis of persistent atrial fibrillation(AF) or long-standing persistent AF by medical history and Holter monitoring (persistent AF lasting more than 7 days; long-standing persistent AF lasting more than 1 year).
- Rheumatic mitral valve disease(RMVD) requires mitral valve surgery( RMVD was determined by history of acute rheumatic fever, valve morphology, echocardiographic findings and pathological diagnosis).
- Consent to surgical ablation of AF
Exclusion Criteria:
- Paroxysmal AF
- Degenerative or ischemic mitral valve disease
- Evidence of active infection
- Previous catheter ablation or surgical ablation for AF
- Surgical management of hypertrophic obstructive cardiomyopathy
- Absolute contraindications for anticoagulation therapy
- Left atrial thrombosis (not including left atrial appendage thrombosis alone)
- Chronic obstructive pulmonary disease(Forced expiratory volume in 1 second (FEV1)<30% anticipated value)
- Uncontrolled hypo- or hyperthyroidism
- Mental impairment or other conditions that may not allow participants to understand the nature, significance, and scope of study
- Left atrial diameter>70mm
- Right ventricular dysfunction (TAPSE<16) or moderate to severe tricuspid regurgitation or pulmonary artery pressure (estimated by echocardiography) >60mmHg
- Coronary artery bypass grafting is required for participants with coronary heart disease
- Previous cardiac surgery
- Refuse to participate in this study
Sites / Locations
- Fuwai HospitalRecruiting
- Nanjing First Hospital, Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bi-atrial ablation group
Left atrial ablation group
Arm Description
Participants in this group will receive mitral valve surgery concomitant with bi-atrial ablation procedure.
Participants in this group will receive mitral valve surgery concomitant with left atrial ablation procedure.
Outcomes
Primary Outcome Measures
Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs
Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring in the absence of antiarrhythmic drugs.
Secondary Outcome Measures
Survival rate without permanent pacemaker implantation (Key secondary outcome)
Percentage of participants who did not have a new permanent pacemaker implanted.
Survival rate without any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs
Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring with antiarrhythmic drugs.
Burden of atrial fibrillation
Burden of atrial fibrillation according to 3-day Holter monitoring.
Major adverse events
Including cardiac death, stroke, heart failure requiring rehospitalization, embolic events or bleeding events requiring rehospitalization.
Cardiac function
Documented by echocardiography (left ventricular ejection fraction).
Full Information
NCT ID
NCT05021601
First Posted
August 16, 2021
Last Updated
March 27, 2023
Sponsor
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT05021601
Brief Title
Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation
Official Title
Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation: a Multicenter, Prospective, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is aimed to compare the efficacy of bi-atrial ablation with left atrial ablation for atrial fibrillation during mitral valve surgery in patients with rheumatic mitral valve disease.
Detailed Description
Atrial fibrillation (AF) is present in 40%-60% of patients with rheumatic mitral valve disease (RMVD), which is an independent predictor of mortality and late stroke. During mitral valve (MV) surgery, the open left atrium facilitates a bi-atrial ablation procedure. However, a simplified lesion set including isolated pulmonary vein isolation or posterior left atrial (LA) wall isolation or LA maze was usually applied. The current literatures provide insufficient evidence to determine the potential benefits of bi-atrial ablation procedure when comparing with LA ablation procrdure in patients with non-paroxysmal AF and RMVD.
Patients with RMVD often have longer history, which tends to affect the right atrium, including pulmonary hypertension or tricuspid regurgitation.The necessity of bi-atrial ablation procedure targeting the bi-atrial substrate for AF in RMVD requires to be explored. In this study, we aimed to compare the efficacy of bi-atrial ablation with LA ablation for AF during MV surgery in patients with RMVD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Rheumatic mitral valve disease, Surgical ablation, Mitral valve surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bi-atrial ablation group
Arm Type
Experimental
Arm Description
Participants in this group will receive mitral valve surgery concomitant with bi-atrial ablation procedure.
Arm Title
Left atrial ablation group
Arm Type
Active Comparator
Arm Description
Participants in this group will receive mitral valve surgery concomitant with left atrial ablation procedure.
Intervention Type
Procedure
Intervention Name(s)
Bi-atrial ablation
Intervention Description
This intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation.
Intervention Type
Procedure
Intervention Name(s)
Left atrial ablation
Intervention Description
This intervention includes mitral valve surgery concomitant with left atrial ablation alone.
Primary Outcome Measure Information:
Title
Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs
Description
Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring in the absence of antiarrhythmic drugs.
Time Frame
At 12-month after intervention
Secondary Outcome Measure Information:
Title
Survival rate without permanent pacemaker implantation (Key secondary outcome)
Description
Percentage of participants who did not have a new permanent pacemaker implanted.
Time Frame
At 12-month after intervention
Title
Survival rate without any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs
Description
Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring with antiarrhythmic drugs.
Time Frame
At 12-month after intervention
Title
Burden of atrial fibrillation
Description
Burden of atrial fibrillation according to 3-day Holter monitoring.
Time Frame
At 12-month after intervention
Title
Major adverse events
Description
Including cardiac death, stroke, heart failure requiring rehospitalization, embolic events or bleeding events requiring rehospitalization.
Time Frame
At 12-month after intervention
Title
Cardiac function
Description
Documented by echocardiography (left ventricular ejection fraction).
Time Frame
At 12-month after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Diagnosis of persistent atrial fibrillation(AF) or long-standing persistent AF by medical history and Holter monitoring (persistent AF lasting more than 7 days; long-standing persistent AF lasting more than 1 year).
Rheumatic mitral valve disease(RMVD) requires mitral valve surgery( RMVD was determined by history of acute rheumatic fever, valve morphology, echocardiographic findings and pathological diagnosis).
Consent to surgical ablation of AF
Exclusion Criteria:
Paroxysmal AF
Degenerative or ischemic mitral valve disease
Evidence of active infection
Previous catheter ablation or surgical ablation for AF
Surgical management of hypertrophic obstructive cardiomyopathy
Absolute contraindications for anticoagulation therapy
Left atrial thrombosis (not including left atrial appendage thrombosis alone)
Chronic obstructive pulmonary disease(Forced expiratory volume in 1 second (FEV1)<30% anticipated value)
Uncontrolled hypo- or hyperthyroidism
Mental impairment or other conditions that may not allow participants to understand the nature, significance, and scope of study
Left atrial diameter>70mm
Right ventricular dysfunction (TAPSE<16) or moderate to severe tricuspid regurgitation or pulmonary artery pressure (estimated by echocardiography) >60mmHg
Coronary artery bypass grafting is required for participants with coronary heart disease
Previous cardiac surgery
Refuse to participate in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe Zheng, MD,PhD
Phone
: +86-010-88396051
Email
zhengzhe@fuwai.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haojie Li, MD
Email
lihaojiefuwai@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhe Zheng, MD,PhD
Organizational Affiliation
Fuwai Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haojie Li, MD
Email
lihaojiefuwai@126.com
Facility Name
Nanjing First Hospital, Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Chen
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation
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