HD Mapping of Atrial Fibrillation in Asia Pacific

HD Mapping Observational Study - Asia Pacific

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Catheter ablation

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • Sir Run Run Shaw Hospital
  • Xi'an, China
    • The Second Affiliated Hospital of Xian Jiaotong University
• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
• Japan
  • Kanagawa, Japan
    • Yokosuka Kyosai Hospital
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Saga, Japan
    • Saga University Hospital
  • Sagamihara, Japan
    • Kitasato University Hospital
  • Tama, Japan
    • Kyorin University Hospital
  • Ōgaki, Japan
    • Ogaki Municipal Hospital
  • Fukuoka
    • Kitakyushu-shi, Fukuoka, Japan, 802-8555
      • Kokura Memorial Hospital
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 305-8576
      • University of Tsukuba Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
• Taiwan
  • Kaohsiung City, Taiwan
    • Kaohsiung Chang Gung Memorial Hospital
  • Taipei City, Taiwan
    • Taipei Veterans General Hospital (VGH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Acute Success of RF Ablation After Electroanatomical Mapping With HD Mapping Catheters.	The rate of acute success was 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). This measure is presented here as the number of participants with acute success, and the associated percentage of subjects (proportion * 100%) with acute success is also displayed as the result of an automatic calculation.	End of Procedure
Number of Participants With Clinical Long-Term Success	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 AADs. This measure is presented here as the number of participants, and the associated percentage of subjects (proportion * 100%) is also displayed as the result of an automatic calculation.	12 months post-procedure
Number of Participants With AAD-Free Long-Term Success	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. This measure is presented here as the number of participants, and the associated percentage of subjects (proportion * 100%) is also displayed as the result of an automatic calculation.	12-month post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Procedure Time	Defined as time from initial catheter insertion to final catheter removal. This is one measure of the amount of time it took for the physician to use invasive tools (catheters) during the procedure to investigate, diagnose, and treat the participant's heart condition.	During Procedure
Radiofrequency (RF) Time	Defined as duration of time radiofrequency energy is delivered. This is a measure the amount of time the physician was actively applying treatment to the heart to treat the participant's heart condition.	During Procedure
Fluoroscopy Time	Defined as total time subject is exposed to fluoroscopy. Fluoroscopy is a type of medical imaging that uses x-rays. This imaging is used by the physician to facilitate a safe and effective procedure. Less fluoroscopy time may help reduce the risk of issues related to x-ray exposure, however other factors such as fluroscopy intensity (not measured in this study) may also be important.	During Procedure
Mapping Time Associated With Mapping Arrhythmia	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). As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity. The information in the map may be used by the physician to plan the treatment strategy. Mapping time provides a measure of how much time the physician spent creating, updating, and analyzing maps during the procedure. A short mapping time is not necessarily better or worse than a long mapping time, as other factors such as the amount and type of information gathered may also affect how useful the map is to the physician.	During Procedure
Number of Mapping Points Collected	Defined as total number of mapping points collected for the creation of each map. As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity. The information in the map may be used by the physician to plan the treatment strategy. Number of mapping points collected is a measure of how much information was collected. A small number of mapping points collected is not necessarily better or worse than a large number of points, as other factors such as the amount of time spent and type of information gathered may also affect how useful the map is to the physician.	During Procedure
Number of Mapping Points Used	Defined as the total number of mapping points used in each map. As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity. The information in the map may be used by the physician to plan the treatment strategy. Number of mapping points collected is a measure of how much information was collected, while number of mapping points used is a measure of how many such points were considered useful. A small number of mapping points used is not necessarily better or worse than a large number of points, as other factors such as the amount of time spent and type of information gathered may also affect how useful the map is to the physician.	During Procedure
Number of Used Mapping Points Per Minute	Defined as the total number of mapping points used divided by the relative mapping time. As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity. The information in the map may be used by the physician to plan the treatment strategy. Mapping time is a measure of how much time the physician spent collecting, updating, and analyzing the information in the map. Number of mapping points collected is a measure of how much information was collected, while number of mapping points used is a measure of how many such points were considered useful. The number of used mapping points per minute is a measure of how efficient the mapping process is. A larger number of used mapping points per minute may be associated with a more efficient mapping process. Mapping efficiency may be of interest to a physician, however other factors such as the type of information gathered may also be of interest.	During Procedure
Substrate Characteristics Identified	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. As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity or use other tests to characterize the state, function, or health of certain areas of the heart tissue, and to localize certain areas that may be problematic (substrate). These localized characteristics may provide information to the physician that could be used to treat the participant's heart condition. This outcome measure lists common substrate characteristics and the number of subjects for which the characteristic was found or otherwise used as part of the treatment plan.	During Procedure
Ablation Strategy(s) Used	Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians. A physician may use one or more strategies to treat the participant's heart condition, including selectively burning (ablating) certain areas of the heart. This outcome measure lists common ablation strategies and the number of participants that received treatment based on each strategy.	During Procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Adverse events include any device-, procedure-, or death-related events	through study completion, an average of 1 year
Number of Subjects With Repeat Ablations	Rate of repeat ablations was defined as proportion of subjects with an additional ablation procedure to treat indicated cardiac arrhythmia (outside blanking period, if applicable). This measure is presented here as the number of participants, and the associated percentage of subjects (proportion * 100%) is also displayed as the result of an automatic calculation.	12-months post-procedure
Change in Quality of Life (QoL): EQ-5D-5L VAS Score	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. EQ-5D-5L EQ VAS scores range from 0 (worst) to 100 (best). A positive change indicates an improvement.	12-months post-procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Kristin Ruffner, PhD, EP Program Director

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2019
• Primary Completion (Actual): August 13, 2021
• Study Completion (Actual): August 13, 2021

Study Registration Dates

• First Submitted: June 29, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CRD975

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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