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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
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-85 years old;
  2. Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥ 1 week), and is ineffective to one or more anti-arrhythmic drugs;
  3. CHA2DS2-VASc score ≥ 2 points;
  4. The patient is ready to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery;
  5. Provide an informed consent form that is willing to participate in the research, follow-up trials and evaluation procedures.

Exclusion Criteria:

  1. Past left atrial appendage occlusion, atrial fibrillation catheter ablation or surgical ablation history;
  2. There are plans for cardiac surgery within 90 days;
  3. Stroke/transient ischemic attack occurred within 30 days;
  4. Have had atrial septal defect repair or have an ASD/PFO occluder in the body;
  5. Heart failure NYHA heart function grade IV;
  6. LVEF<30%;
  7. Combined with other serious diseases, the life expectancy is less than 2 years;
  8. Within 6 months after cardiac revascularization or other cardiac surgery;
  9. Women who are pregnant, breastfeeding, planning to become pregnant, or women of childbearing age who have not adopted reliable contraceptive methods;
  10. 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

    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
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    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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    Citation
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    Left Atrial Appendage Electrical Isolation in Persistent Atrial Fibrillation

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