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Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis.

Primary Purpose

Persistent Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation
Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation
Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring persistent atrial fibrillation, severe atrial fibrosis, driver ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18 to 80 years old;
  2. Persistent AF with severe atrial fibrosis;
  3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Exclusion Criteria:

  1. With uncontrolled congestive heart failure;
  2. Having significant valvular disease;
  3. With myocardial infarction or stroke within 6 months of screening;
  4. With Significant congenital heart disease;
  5. Ejection fraction was <40% measured by echocardiography;
  6. Allergic to contrast media;
  7. Contraindication to anticoagulation medications;
  8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
  9. Left atrial (LA) thrombus;
  10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;

12. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Group A

    Group B

    Group C

    Arm Description

    Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation

    Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation

    Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion

    Outcomes

    Primary Outcome Measures

    Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
    AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration
    Intraoperative AF termination rate
    AF termination is defined as conversion to sinus rhythm or stable AFL/AT.

    Secondary Outcome Measures

    Postoperative AF recurrence rate
    AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
    Postoperative AFL/AT rate
    occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration
    Incidence of complications
    death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis and major vascular access complication or bleeding
    Changes in the diameter of the left atrium
    Changes in the diameter of the left atrium
    Changes in the left ventricular ejection fraction
    Changes in the left ventricular ejection fraction

    Full Information

    First Posted
    October 5, 2021
    Last Updated
    October 18, 2021
    Sponsor
    Shanghai Chest Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05085912
    Brief Title
    Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis.
    Official Title
    A Randomized Control Study of Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis: a Chinese Registry Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2021 (Anticipated)
    Primary Completion Date
    October 31, 2024 (Anticipated)
    Study Completion Date
    October 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Chest Hospital

    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 is an open label, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.
    Detailed Description
    This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation) and group C (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion). Postoperative recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Persistent Atrial Fibrillation
    Keywords
    persistent atrial fibrillation, severe atrial fibrosis, driver ablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation
    Arm Title
    Group C
    Arm Type
    Active Comparator
    Arm Description
    Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion
    Intervention Type
    Procedure
    Intervention Name(s)
    Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation
    Intervention Description
    Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation
    Intervention Description
    Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with posterior wall box isolation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion
    Intervention Description
    Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion.
    Primary Outcome Measure Information:
    Title
    Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
    Description
    AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration
    Time Frame
    up to 12 months after ablation
    Title
    Intraoperative AF termination rate
    Description
    AF termination is defined as conversion to sinus rhythm or stable AFL/AT.
    Time Frame
    through ablation completion, an average of 3 hours
    Secondary Outcome Measure Information:
    Title
    Postoperative AF recurrence rate
    Description
    AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
    Time Frame
    up to 12 months after ablation
    Title
    Postoperative AFL/AT rate
    Description
    occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration
    Time Frame
    up to 12 months after ablation
    Title
    Incidence of complications
    Description
    death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis and major vascular access complication or bleeding
    Time Frame
    up to 12 months after ablation
    Title
    Changes in the diameter of the left atrium
    Description
    Changes in the diameter of the left atrium
    Time Frame
    up to 12 months after ablation
    Title
    Changes in the left ventricular ejection fraction
    Description
    Changes in the left ventricular ejection fraction
    Time Frame
    up to 12 months after ablation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18 to 80 years old; Persistent AF with severe atrial fibrosis; Nonresponse or intolerance to ≥1 antiarrhythmic drug. Exclusion Criteria: With uncontrolled congestive heart failure; Having significant valvular disease; With myocardial infarction or stroke within 6 months of screening; With Significant congenital heart disease; Ejection fraction was <40% measured by echocardiography; Allergic to contrast media; Contraindication to anticoagulation medications; Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD); Left atrial (LA) thrombus; Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation; 12. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mu Qin, M.D.
    Phone
    +8613052320103
    Email
    qinmuae@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis.

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