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High-density Mapping-guided bOx Isolation and subsTrate Ablation (HOT)

Primary Purpose

Atrial Fibrillation, Atrial Remodeling

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPVI
CPVI+BOX
CPVI+BOX+SUB
Sponsored by
The Third Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring catheter ablation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent signed.
  • Age of 18 to 75 years old.
  • Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months.
  • Willing to have catheter ablation for atrial fibrillation.

Exclusion Criteria:

  • Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on.
  • Complete atrioventricular block.
  • An acute stroke or contradiction of anti-coagulation.
  • Hyperthyroidism.
  • Having a history of catheter ablation of atrial fibrillation.
  • Left atrial appendage thrombosis confirmed by transesophageal echocardiography.
  • Pregnancy or lactation.
  • Planning for pregnancy in the near future.
  • Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal.
  • Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Circumferential PV isolation

    Circumferential PV and BOX isolation

    circumferential PV and BOX isolation with substrate ablation

    Arm Description

    Circumferential PV isolation only

    Circumferential PV and BOX isolation

    Atrial substrate ablation apart from circumferential PV and BOX isolation

    Outcomes

    Primary Outcome Measures

    sinus rhythm maintenance rate
    Holter is performed 12months after the procedure and heart rhythm is recorded.

    Secondary Outcome Measures

    left ventricular ejection fraction
    LVEF is evaluated by echocardiography 12months after the procedure.
    Stroke or embolic events
    History of stroke or embolic events is taken at each follow-up during the period of 12 months after procedure, and if necessary, radiographic examinations will be performed.
    Atrial fibrosis
    Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis.

    Full Information

    First Posted
    June 25, 2019
    Last Updated
    June 28, 2019
    Sponsor
    The Third Xiangya Hospital of Central South University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03998956
    Brief Title
    High-density Mapping-guided bOx Isolation and subsTrate Ablation
    Acronym
    HOT
    Official Title
    Study of High-density Mapping-guided bOx Isolation and subsTrate Ablation for Persistent Atrial Fibrillation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2019 (Anticipated)
    Primary Completion Date
    August 31, 2021 (Anticipated)
    Study Completion Date
    August 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Third Xiangya Hospital of Central South University

    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 study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation, Atrial Remodeling
    Keywords
    catheter ablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Circumferential PV isolation
    Arm Type
    Active Comparator
    Arm Description
    Circumferential PV isolation only
    Arm Title
    Circumferential PV and BOX isolation
    Arm Type
    Experimental
    Arm Description
    Circumferential PV and BOX isolation
    Arm Title
    circumferential PV and BOX isolation with substrate ablation
    Arm Type
    Experimental
    Arm Description
    Atrial substrate ablation apart from circumferential PV and BOX isolation
    Intervention Type
    Procedure
    Intervention Name(s)
    CPVI
    Intervention Description
    Circumferential PV isolation only
    Intervention Type
    Procedure
    Intervention Name(s)
    CPVI+BOX
    Intervention Description
    Circumferential PV and BOX isolation
    Intervention Type
    Procedure
    Intervention Name(s)
    CPVI+BOX+SUB
    Intervention Description
    Atrial substrate ablation apart from circumferential PV and BOX isolation
    Primary Outcome Measure Information:
    Title
    sinus rhythm maintenance rate
    Description
    Holter is performed 12months after the procedure and heart rhythm is recorded.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    left ventricular ejection fraction
    Description
    LVEF is evaluated by echocardiography 12months after the procedure.
    Time Frame
    12 months
    Title
    Stroke or embolic events
    Description
    History of stroke or embolic events is taken at each follow-up during the period of 12 months after procedure, and if necessary, radiographic examinations will be performed.
    Time Frame
    12 months
    Title
    Atrial fibrosis
    Description
    Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis.
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Informed consent signed. Age of 18 to 75 years old. Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months. Willing to have catheter ablation for atrial fibrillation. Exclusion Criteria: Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on. Complete atrioventricular block. An acute stroke or contradiction of anti-coagulation. Hyperthyroidism. Having a history of catheter ablation of atrial fibrillation. Left atrial appendage thrombosis confirmed by transesophageal echocardiography. Pregnancy or lactation. Planning for pregnancy in the near future. Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal. Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.

    12. IPD Sharing Statement

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    High-density Mapping-guided bOx Isolation and subsTrate Ablation

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