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出境医 / 临床实验 / HD Mapping of Atrial Fibrillation in Asia Pacific

HD Mapping of Atrial Fibrillation in Asia Pacific

Study Description
Brief Summary:
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with the EnSite Cardiac Mapping System and the EnSite Automap module in subjects with AF in the real-world environment of the Asian population.

Condition or disease Intervention/treatment
Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation Device: Catheter ablation

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: HD Mapping Observational Study - Asia Pacific
Actual Study Start Date : September 11, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : April 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Inquiry™ AFocusII™ Double Loop
The Inquiry™ AFocus™ catheters are for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocus™ catheters are for use in mapping atrial regions of the heart.
Device: Catheter ablation
Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled

Advisor™ HD Grid, Sensor Enabled™
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart with recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Device: Catheter ablation
Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled

Outcome Measures
Primary Outcome Measures :
  1. Acute- and long-term success rate of RF ablation after electroanatomical mapping with HD mapping catheters. [ Time Frame: 12-months post-procedure ]
    The rate of acute success defined as the proportion of subjects who receive HD mapping and RF energy delivery resulting in acute termination of clinical arrhythmia, defined by termination to SR (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt). The rate of long-term success defined as the proportion of subjects who receive HD mapping and RF energy delivery with pre-defined procedural endpoints: AF freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and on or off class I/III antiarrhythmic drug (AAD). AF freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and off all class I/III AADs.


Secondary Outcome Measures :
  1. Overall Procedure Time [ Time Frame: During Procedure ]
    Defined as time from initial catheter insertion to final catheter removal.

  2. Radiofrequency (RF) Time [ Time Frame: During Procedure ]
    Defined as duration of time RF energy is delivered

  3. Fluoroscopy time [ Time Frame: During Procedure ]
    Defined as total time subject is exposed to fluoroscopy

  4. Mapping time associated with mapping arrhythmia [ Time Frame: During Procedure ]
    Defined as the total cumulative mapping time and mapping time for the creation of each map (including any new or retrospective map created with Manual, AutoMap, and TurboMap mapping)

  5. Number of mapping points collected [ Time Frame: During Procedure ]
    Defined as total number of mapping points collected for the creation of each map

  6. Number of mapping points used [ Time Frame: During Procedure ]
    Defined as the total number of mapping points used in each map

  7. Number of used mapping points per minute [ Time Frame: During Procedure ]
    Defined as the total number of mapping points used divided by the relative mapping time

  8. Substrate characteristics identified [ Time Frame: During Procedure ]
    For each type of arrhythmogenic substrate this will be defined as the frequency of substrate type identified in cases that attempted to identify the specific substrate

  9. Ablation strategy(s) used [ Time Frame: During Procedure ]
    Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians


Other Outcome Measures:
  1. Number of participants with adverse events [ Time Frame: through study completion, an average of 1 year ]
    Adverse events include any device-, procedure-, or death-related events

  2. Rate of repeat ablations [ Time Frame: through study completion, an average of 1 year ]
    Defined as proportion of subjects with an additional ablation procedure to treat indicated cardiac arrhythmia (outside blanking period, if applicable).

  3. Change in Quality of Life (QoL): EQ-5D-5L [ Time Frame: through study completion, an average of 1 year ]
    Defined as change in quality of life score assessed by the validated QoL survey, EQ-5D-5L. The EQ-5D-5L is a descriptive system comprised of five questions related to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The analysis population used for all endpoints will include all subjects who have signed the Informed Consent Form and have undergone the electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol. If any device used during the procedure is used off-label, the subject will be excluded from non-safety related endpoint analysis and any additional evaluations
Criteria

Inclusion Criteria:

  1. Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule
  2. Subject must be over 18 years of age. (In Japan, the subject must be of 20 years of age or older)
  3. Subject is diagnosed with AF as defined by:

    • Documented symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within 7 days of onset
    • Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months
  4. Subject is indicated for cardiac electroanatomical mapping and RF ablation procedure to treat AF
  5. Subject is planned to have electroanatomical mapping performed with the HD mapping catheters under investigation

Exclusion Criteria:

  1. Previous ablation or surgery in the left atria
  2. Implanted left atrial appendage occluder
  3. Implanted mitral or tricuspid valve replacement
  4. Implanted cardiac defibrillator (ICD)
  5. Participation in another clinical investigation that may confound the results of this study
  6. Pregnant or nursing
  7. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  8. Life expectancy less than 12 months
Contacts and Locations

Locations
Layout table for location information
China
Sir Run Run Shaw Hospital
Hangzhou, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, China
Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Japan
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, Japan, 802-8555
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan, 305-8576
Yokosuka Kyosai Hospital
Kanagawa, Japan
Kyoto University Hospital
Kyoto, Japan, 606-8507
Kitasato University Hospital
Sagamihara, Japan
Saga University Hospital
Saga, Japan
Kyorin University Hospital
Tama, Japan
Ogaki Municipal Hospital
Ōgaki, Japan
Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Taipei Veterans General Hospital (VGH)
Taipei City, Taiwan
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Study Director: Kristin Ruffner, PhD EP Program Director
Tracking Information
First Submitted Date June 29, 2019
First Posted Date July 17, 2019
Last Update Posted Date October 8, 2020
Actual Study Start Date September 11, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2019)
Acute- and long-term success rate of RF ablation after electroanatomical mapping with HD mapping catheters. [ Time Frame: 12-months post-procedure ]
The rate of acute success defined as the proportion of subjects who receive HD mapping and RF energy delivery resulting in acute termination of clinical arrhythmia, defined by termination to SR (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt). The rate of long-term success defined as the proportion of subjects who receive HD mapping and RF energy delivery with pre-defined procedural endpoints: AF freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and on or off class I/III antiarrhythmic drug (AAD). AF freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and off all class I/III AADs.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 16, 2019)
  • Overall Procedure Time [ Time Frame: During Procedure ]
    Defined as time from initial catheter insertion to final catheter removal.
  • Radiofrequency (RF) Time [ Time Frame: During Procedure ]
    Defined as duration of time RF energy is delivered
  • Fluoroscopy time [ Time Frame: During Procedure ]
    Defined as total time subject is exposed to fluoroscopy
  • Mapping time associated with mapping arrhythmia [ Time Frame: During Procedure ]
    Defined as the total cumulative mapping time and mapping time for the creation of each map (including any new or retrospective map created with Manual, AutoMap, and TurboMap mapping)
  • Number of mapping points collected [ Time Frame: During Procedure ]
    Defined as total number of mapping points collected for the creation of each map
  • Number of mapping points used [ Time Frame: During Procedure ]
    Defined as the total number of mapping points used in each map
  • Number of used mapping points per minute [ Time Frame: During Procedure ]
    Defined as the total number of mapping points used divided by the relative mapping time
  • Substrate characteristics identified [ Time Frame: During Procedure ]
    For each type of arrhythmogenic substrate this will be defined as the frequency of substrate type identified in cases that attempted to identify the specific substrate
  • Ablation strategy(s) used [ Time Frame: During Procedure ]
    Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 30, 2019)
  • Number of participants with adverse events [ Time Frame: through study completion, an average of 1 year ]
    Adverse events include any device-, procedure-, or death-related events
  • Rate of repeat ablations [ Time Frame: through study completion, an average of 1 year ]
    Defined as proportion of subjects with an additional ablation procedure to treat indicated cardiac arrhythmia (outside blanking period, if applicable).
  • Change in Quality of Life (QoL): EQ-5D-5L [ Time Frame: through study completion, an average of 1 year ]
    Defined as change in quality of life score assessed by the validated QoL survey, EQ-5D-5L. The EQ-5D-5L is a descriptive system comprised of five questions related to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Original Other Pre-specified Outcome Measures
 (submitted: July 16, 2019)
  • Adverse events [ Time Frame: through study completion, an average of 1 year ]
    Adverse events including any device-, procedure-, or death-related events
  • Rate of repeat ablations [ Time Frame: through study completion, an average of 1 year ]
    Defined as proportion of subjects with an additional ablation procedure to treat indicated cardiac arrhythmia (outside blanking period, if applicable).
  • Change in Quality of Life (QoL): EQ-5D-5L [ Time Frame: through study completion, an average of 1 year ]
    Defined as change in quality of life assessed in validated QoL surveys (EQ-5D-5L)
 
Descriptive Information
Brief Title HD Mapping of Atrial Fibrillation in Asia Pacific
Official Title HD Mapping Observational Study - Asia Pacific
Brief Summary The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with the EnSite Cardiac Mapping System and the EnSite Automap module in subjects with AF in the real-world environment of the Asian population.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The analysis population used for all endpoints will include all subjects who have signed the Informed Consent Form and have undergone the electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol. If any device used during the procedure is used off-label, the subject will be excluded from non-safety related endpoint analysis and any additional evaluations
Condition
  • Paroxysmal Atrial Fibrillation
  • Persistent Atrial Fibrillation
Intervention Device: Catheter ablation
Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled
Study Groups/Cohorts
  • Inquiry™ AFocusII™ Double Loop
    The Inquiry™ AFocus™ catheters are for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocus™ catheters are for use in mapping atrial regions of the heart.
    Intervention: Device: Catheter ablation
  • Advisor™ HD Grid, Sensor Enabled™
    The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart with recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
    Intervention: Device: Catheter 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 Active, not recruiting
Actual Enrollment
 (submitted: July 16, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule
  2. Subject must be over 18 years of age. (In Japan, the subject must be of 20 years of age or older)
  3. Subject is diagnosed with AF as defined by:

    • Documented symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within 7 days of onset
    • Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months
  4. Subject is indicated for cardiac electroanatomical mapping and RF ablation procedure to treat AF
  5. Subject is planned to have electroanatomical mapping performed with the HD mapping catheters under investigation

Exclusion Criteria:

  1. Previous ablation or surgery in the left atria
  2. Implanted left atrial appendage occluder
  3. Implanted mitral or tricuspid valve replacement
  4. Implanted cardiac defibrillator (ICD)
  5. Participation in another clinical investigation that may confound the results of this study
  6. Pregnant or nursing
  7. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  8. Life expectancy less than 12 months
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China,   Hong Kong,   Japan,   Korea, Republic of,   Taiwan
Removed Location Countries India
 
Administrative Information
NCT Number NCT04022954
Other Study ID Numbers CRD975
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators
Study Director: Kristin Ruffner, PhD EP Program Director
PRS Account Abbott Medical Devices
Verification Date October 2020