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出境医 / 临床实验 / Efficacy of High Density Voltage and Fractionation Map Guided Ablation in Patients With Atrial Fibrillation (INVENTION)

Efficacy of High Density Voltage and Fractionation Map Guided Ablation in Patients With Atrial Fibrillation (INVENTION)

Study Description
Brief Summary:
The purpose of this study is to evaluate the efficacy of high density voltage and fractionation map guided ablation compared to anatomy-based circumferential pulmonary vein Isolation in patients with atrial fibrillation

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: AF ablation Not Applicable

Detailed Description:
In this study, a test group includes those who undergoing atrial fibrillation(AF) ablation guided by high density voltage and fractionation map. A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential pulmonary vein (PV) isolation.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of High Density Voltage and Fractionation Map Guided Ablation Compared to Anatomy-based Circumferential Pulmonary Vein Isolation in Patients With Atrial Fibrillation
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : May 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: High density voltage and fractionation map guided group
  • Complex fractionated atrial electrogram (CFAE), voltage and fractionation map will be performed with a multielectrode mapping catheter.
  • The mapping should be performed in AF.
  • First, low-voltage zone is defined as an area with bipolar peak-to-peak voltage amplitudes < 0.5mV.
  • A voltage-map guided segmental PV isolation is performed. Radiofrequency energy is applied in the antral regions of the PVs. High voltage zone over 0.5mV in the antral region is targeted. IF PV isolation in not achieved by voltage-guided segmental ablation, additional Lasso catheter guided segmental antral ablation is performed.
  • Radiofrequency energy is delivered at target sites for 15-30 sec guided by contact force, lesion size index (LSI) and local electrogram elimination.
  • If the patient is still in AF after PV isolation, additional fractionation map guided ablation is performed. The fractionation area within low voltage area (<0.5mV) should be targeted.
 Procedure: AF ablation
AF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation
Active Comparator: Circumferential PV isolation
A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential PV isolation.
 Procedure: AF ablation
AF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation
Outcome Measures
Primary Outcome Measures :
  1. Free from atrial arrhythmia at 12 months [ Time Frame: 12 months ]
    Freedom from any atrial arrhythmia lasting longer than 30 seconds during 1 year follow-up after single ablation with or without the use of antiarrhythmic medications with the exclusion of the 3-month blanking period.


Secondary Outcome Measures :
  1. Acute AF termination rate during the procedure [ Time Frame: During the procedure ]
    Acute AF termination rate during the procedure

  2. Complication rate [ Time Frame: 12 months ]
    Compare complication rate between two groups

  3. Total procedure time, ablation time, fluoroscopy time [ Time Frame: 12 months ]
    Total procedure time, ablation time, fluoroscopy time between two groups


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Age over 20 years old and under 80 years old 2. Patients with non-valvular atrial fibrillation 3. Patients having AF even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks 4. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them 5. Patients who are available of follow-up at least for more than three months after catheter ablation

Exclusion Criteria:

  1. Patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm
  2. Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
  3. Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
  4. Patients in the subject group vulnerable to clinical study
  5. Patients who had undergone a prior catheter ablation for atrial fibrillation
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Hyoung-Seob Park, MD +82-53-258-7725 drparkgyver@gmail.com

Locations
Layout table for location information
Korea, Republic of
Keimyung University Dongsan Hospital Recruiting
Daegu, Korea, Republic of, 42602
Contact: Hyoung-Seob Park, MD    82532507473    drparkgyver@gmail.com   
Principal Investigator: Hyoung-Seob Park, MD         
Sponsors and Collaborators
Keimyung University Dongsan Medical Center
Abbott
Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019) 		Free from atrial arrhythmia at 12 months [ Time Frame: 12 months ]
Freedom from any atrial arrhythmia lasting longer than 30 seconds during 1 year follow-up after single ablation with or without the use of antiarrhythmic medications with the exclusion of the 3-month blanking period.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Acute AF termination rate during the procedure [ Time Frame: During the procedure ]
    Acute AF termination rate during the procedure
  • Complication rate [ Time Frame: 12 months ]
    Compare complication rate between two groups
  • Total procedure time, ablation time, fluoroscopy time [ Time Frame: 12 months ]
    Total procedure time, ablation time, fluoroscopy time between two groups
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 Efficacy of High Density Voltage and Fractionation Map Guided Ablation in Patients With Atrial Fibrillation
Official Title  ICMJE Efficacy of High Density Voltage and Fractionation Map Guided Ablation Compared to Anatomy-based Circumferential Pulmonary Vein Isolation in Patients With Atrial Fibrillation
Brief Summary The purpose of this study is to evaluate the efficacy of high density voltage and fractionation map guided ablation compared to anatomy-based circumferential pulmonary vein Isolation in patients with atrial fibrillation
Detailed Description In this study, a test group includes those who undergoing atrial fibrillation(AF) ablation guided by high density voltage and fractionation map. A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential pulmonary vein (PV) isolation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Procedure: AF ablation
AF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation
Study Arms  ICMJE
  • Experimental: High density voltage and fractionation map guided group
    • Complex fractionated atrial electrogram (CFAE), voltage and fractionation map will be performed with a multielectrode mapping catheter.
    • The mapping should be performed in AF.
    • First, low-voltage zone is defined as an area with bipolar peak-to-peak voltage amplitudes < 0.5mV.
    • A voltage-map guided segmental PV isolation is performed. Radiofrequency energy is applied in the antral regions of the PVs. High voltage zone over 0.5mV in the antral region is targeted. IF PV isolation in not achieved by voltage-guided segmental ablation, additional Lasso catheter guided segmental antral ablation is performed.
    • Radiofrequency energy is delivered at target sites for 15-30 sec guided by contact force, lesion size index (LSI) and local electrogram elimination.
    • If the patient is still in AF after PV isolation, additional fractionation map guided ablation is performed. The fractionation area within low voltage area (<0.5mV) should be targeted.
    Intervention: Procedure: AF ablation
  • Active Comparator: Circumferential PV isolation
    A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential PV isolation.
    Intervention: Procedure: AF ablation
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 14, 2019) 		160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Age over 20 years old and under 80 years old 2. Patients with non-valvular atrial fibrillation 3. Patients having AF even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks 4. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them 5. Patients who are available of follow-up at least for more than three months after catheter ablation

Exclusion Criteria:

  1. Patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm
  2. Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
  3. Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
  4. Patients in the subject group vulnerable to clinical study
  5. Patients who had undergone a prior catheter ablation for atrial fibrillation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03989726
Other Study ID Numbers  ICMJE DSMCEP_PHS_003
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Responsible Party Keimyung University Dongsan Medical Center
Study Sponsor  ICMJE Keimyung University Dongsan Medical Center
Collaborators  ICMJE Abbott
Investigators  ICMJE Not Provided
PRS Account Keimyung University Dongsan Medical Center
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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