Left Atrial Appendage Electrical Isolation in Persistent Atrial Fibrillation
Primary Purpose
Atrial Fibrillation, Left Atrial Appendage, Left Atrial Appendage Occlusion
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Catheter ablation and left atrial appendage occlusion
Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Left Atrial Appendage Electrical Isolation, Atrial Fibrillation, Catheter Ablation
Eligibility Criteria
Inclusion Criteria:
- Age 18-85 years old;
- Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥ 1 week), and is ineffective to one or more anti-arrhythmic drugs;
- CHA2DS2-VASc score ≥ 2 points;
- The patient is ready to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery;
- Provide an informed consent form that is willing to participate in the research, follow-up trials and evaluation procedures.
Exclusion Criteria:
- Past left atrial appendage occlusion, atrial fibrillation catheter ablation or surgical ablation history;
- There are plans for cardiac surgery within 90 days;
- Stroke/transient ischemic attack occurred within 30 days;
- Have had atrial septal defect repair or have an ASD/PFO occluder in the body;
- Heart failure NYHA heart function grade IV;
- LVEF<30%;
- Combined with other serious diseases, the life expectancy is less than 2 years;
- Within 6 months after cardiac revascularization or other cardiac surgery;
- Women who are pregnant, breastfeeding, planning to become pregnant, or women of childbearing age who have not adopted reliable contraceptive methods;
- Obviously abnormal liver and kidney function and coagulation function;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Left Atrial Appendage Electrical Isolation with One-stop treatment of atrial fibrillation
One-stop treatment of atrial fibrillation
Arm Description
The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion and additional left atrial appendage electrical isolation operation.
The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion.
Outcomes
Primary Outcome Measures
Atrial fibrillation recurrence
outside the 3-month blank period after surgery, ECG and Holter recorded rapid atrial arrhythmia greater than 30S.
Stroke/TIA
Patients may have cerebral ischemia, such as sudden limb movement and sensory disturbance, aphasia, transient blindness in one eye, etc., disturbance of consciousness, or symptoms of vertebral artery ischemia, such as vertigo, tinnitus, hearing impairment, diplopia, Unsteady gait and difficulty swallowing, etc., patients may have obvious infarcts in the brain, which can be confirmed clinically by CT or MRI.
Systemic embolism
The clinical manifestations or evidence of embolism in the blood vessels of the system, including renal artery, splenic artery, mesenteric artery, etc. during the follow-up of the patient, and relevant examinations can be used to confirm the diagnosis.
Hospitalization rate due to heart failure
During the follow-up period, patients need hospitalization for heart failure, including acute heart failure, acute exacerbation of chronic heart failure, etc., which can be combined with clinical symptoms, signs, biochemical examinations (such as NT-proBNP) and cardiac ultrasound Wait for a clear diagnosis.
Cardiovascular death
The death of a patient due to cardiac structure, function, coronary artery disease, and arrhythmia can be diagnosed in combination with clinical practice.
Secondary Outcome Measures
Full Information
NCT ID
NCT04897204
First Posted
May 19, 2021
Last Updated
May 19, 2021
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE
1. Study Identification
Unique Protocol Identification Number
NCT04897204
Brief Title
Left Atrial Appendage Electrical Isolation in Persistent Atrial Fibrillation
Official Title
A Prospective Randomized Controlled Study of Additonal Left Atrial Appendage Electrical Isolation in Catheter Ablation Combined With Left Atrial Appendage Occlusion of Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This project intends to enroll patients with persistent atrial fibrillation who are planning to undergo catheter ablation of atrial fibrillation. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. We are intend to evaluate the safety and effectiveness of one-stop operation of left atrial appendage electrical isolation combined with left atrial appendage occlusion in the treatment of persistent atrial fibrillation.
Detailed Description
This project intends to enroll patients with persistent atrial fibrillation who are planned to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery, and randomly allocate them to the experimental group and the control group at a ratio of 1:1. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. Follow-up for 1 year, compare the differences in the recurrence rate of atrial fibrillation between the two groups of patients, and further compare the differences in clinical events such as stroke, systemic embolism, hospitalization due to heart failure, and cardiovascular death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Left Atrial Appendage, Left Atrial Appendage Occlusion, Catheter Ablation
Keywords
Left Atrial Appendage Electrical Isolation, Atrial Fibrillation, Catheter Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Left Atrial Appendage Electrical Isolation with One-stop treatment of atrial fibrillation
Arm Type
Experimental
Arm Description
The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion and additional left atrial appendage electrical isolation operation.
Arm Title
One-stop treatment of atrial fibrillation
Arm Type
Other
Arm Description
The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion.
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation and left atrial appendage occlusion
Intervention Description
The patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion.
Intervention Type
Procedure
Intervention Name(s)
Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion
Intervention Description
These patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion, combined with additional left atrial appendage occlusion.
Primary Outcome Measure Information:
Title
Atrial fibrillation recurrence
Description
outside the 3-month blank period after surgery, ECG and Holter recorded rapid atrial arrhythmia greater than 30S.
Time Frame
one year after operation
Title
Stroke/TIA
Description
Patients may have cerebral ischemia, such as sudden limb movement and sensory disturbance, aphasia, transient blindness in one eye, etc., disturbance of consciousness, or symptoms of vertebral artery ischemia, such as vertigo, tinnitus, hearing impairment, diplopia, Unsteady gait and difficulty swallowing, etc., patients may have obvious infarcts in the brain, which can be confirmed clinically by CT or MRI.
Time Frame
one year after operation
Title
Systemic embolism
Description
The clinical manifestations or evidence of embolism in the blood vessels of the system, including renal artery, splenic artery, mesenteric artery, etc. during the follow-up of the patient, and relevant examinations can be used to confirm the diagnosis.
Time Frame
one year after operation
Title
Hospitalization rate due to heart failure
Description
During the follow-up period, patients need hospitalization for heart failure, including acute heart failure, acute exacerbation of chronic heart failure, etc., which can be combined with clinical symptoms, signs, biochemical examinations (such as NT-proBNP) and cardiac ultrasound Wait for a clear diagnosis.
Time Frame
one year after operation
Title
Cardiovascular death
Description
The death of a patient due to cardiac structure, function, coronary artery disease, and arrhythmia can be diagnosed in combination with clinical practice.
Time Frame
one year after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-85 years old;
Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥ 1 week), and is ineffective to one or more anti-arrhythmic drugs;
CHA2DS2-VASc score ≥ 2 points;
The patient is ready to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery;
Provide an informed consent form that is willing to participate in the research, follow-up trials and evaluation procedures.
Exclusion Criteria:
Past left atrial appendage occlusion, atrial fibrillation catheter ablation or surgical ablation history;
There are plans for cardiac surgery within 90 days;
Stroke/transient ischemic attack occurred within 30 days;
Have had atrial septal defect repair or have an ASD/PFO occluder in the body;
Heart failure NYHA heart function grade IV;
LVEF<30%;
Combined with other serious diseases, the life expectancy is less than 2 years;
Within 6 months after cardiac revascularization or other cardiac surgery;
Women who are pregnant, breastfeeding, planning to become pregnant, or women of childbearing age who have not adopted reliable contraceptive methods;
Obviously abnormal liver and kidney function and coagulation function;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qun Shan Wang, Doctor
Phone
008613621878542
Email
wangqunshan@xinhuamed.com.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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12968085
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Learn more about this trial
Left Atrial Appendage Electrical Isolation in Persistent Atrial Fibrillation
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