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出境医 / 临床实验 / High-density Mapping-guided bOx Isolation and subsTrate Ablation (HOT)

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

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Remodeling Procedure: CPVI Procedure: CPVI+BOX Procedure: CPVI+BOX+SUB Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Study of High-density Mapping-guided bOx Isolation and subsTrate Ablation for Persistent Atrial Fibrillation
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Circumferential PV isolation
Circumferential PV isolation only
 Procedure: CPVI
Circumferential PV isolation only
Experimental: Circumferential PV and BOX isolation
Circumferential PV and BOX isolation
 Procedure: CPVI+BOX
Circumferential PV and BOX isolation
Experimental: circumferential PV and BOX isolation with substrate ablation
Atrial substrate ablation apart from circumferential PV and BOX isolation
 Procedure: CPVI+BOX+SUB
Atrial substrate ablation apart from circumferential PV and BOX isolation
Outcome Measures
Primary Outcome Measures :
  1. sinus rhythm maintenance rate [ Time Frame: 12 months ]
    Holter is performed 12months after the procedure and heart rhythm is recorded.


Secondary Outcome Measures :
  1. left ventricular ejection fraction [ Time Frame: 12 months ]
    LVEF is evaluated by echocardiography 12months after the procedure.

  2. Stroke or embolic events [ Time Frame: 12 months ]
    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.

  3. Atrial fibrosis [ Time Frame: 1 day ]
    Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE June 25, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date July 1, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019) 		sinus rhythm maintenance rate [ Time Frame: 12 months ]
Holter is performed 12months after the procedure and heart rhythm is recorded.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • left ventricular ejection fraction [ Time Frame: 12 months ]
    LVEF is evaluated by echocardiography 12months after the procedure.
  • Stroke or embolic events [ Time Frame: 12 months ]
    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 [ Time Frame: 1 day ]
    Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-density Mapping-guided bOx Isolation and subsTrate Ablation
Official Title  ICMJE Study of High-density Mapping-guided bOx Isolation and subsTrate Ablation for Persistent Atrial Fibrillation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Atrial Remodeling
Intervention  ICMJE
  • Procedure: CPVI
    Circumferential PV isolation only
  • Procedure: CPVI+BOX
    Circumferential PV and BOX isolation
  • Procedure: CPVI+BOX+SUB
    Atrial substrate ablation apart from circumferential PV and BOX isolation
Study Arms  ICMJE
  • Active Comparator: Circumferential PV isolation
    Circumferential PV isolation only
    Intervention: Procedure: CPVI
  • Experimental: Circumferential PV and BOX isolation
    Circumferential PV and BOX isolation
    Intervention: Procedure: CPVI+BOX
  • Experimental: circumferential PV and BOX isolation with substrate ablation
    Atrial substrate ablation apart from circumferential PV and BOX isolation
    Intervention: Procedure: CPVI+BOX+SUB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2019) 		200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03998956
Other Study ID Numbers  ICMJE 3rdxiangya@csu
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Third Xiangya Hospital of Central South University
Study Sponsor  ICMJE The Third Xiangya Hospital of Central South University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Third Xiangya Hospital of Central South University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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