HD Mapping of Atrial Fibrillation in Asia Pacific

Completed

Conditions: Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation

Interventions: Device: Catheter ablation

Registration Number: NCT04022954

Lead Sponsor: Abbott Medical Devices

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

Inclusion Criteria

Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule
Subject must be over 18 years of age. (In Japan, the subject must be of 20 years of age or older)
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
Subject is indicated for cardiac electroanatomical mapping and RF ablation procedure to treat AF
Subject is planned to have electroanatomical mapping performed with the HD mapping catheters under investigation

Exclusion Criteria

Previous ablation or surgery in the left atria
Implanted left atrial appendage occluder
Implanted mitral or tricuspid valve replacement
Implanted cardiac defibrillator (ICD)
Participation in another clinical investigation that may confound the results of this study
Pregnant or nursing
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.
Life expectancy less than 12 months

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advisor™ HD Grid, Sensor Enabled™	Catheter ablation	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.
Inquiry™ AFocusII™ Double Loop	Catheter ablation	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acute Success of RF Ablation After Electroanatomical Mapping With HD Mapping Catheters.	End of Procedure	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.
Number of Participants With AAD-Free Long-Term Success	12-month post-procedure	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.
Number of Participants With Clinical Long-Term Success	12 months post-procedure	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.

Secondary Outcome Measures

Name	Time	Method
Fluoroscopy Time	During Procedure	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.
Overall Procedure Time	During Procedure	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.
Substrate Characteristics Identified	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. 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.
Radiofrequency (RF) Time	During Procedure	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.
Number of Used Mapping Points Per Minute	During Procedure	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.
Mapping Time Associated With Mapping Arrhythmia	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). 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.
Number of Mapping Points Collected	During Procedure	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.
Number of Mapping Points Used	During Procedure	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.
Ablation Strategy(s) Used	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. 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.

Trial Locations

Locations (15): Korea University Anam Hospital
🇰🇷
Seoul, Korea, Republic of
Severance Hospital
🇰🇷
Seoul, Korea, Republic of
Yokosuka Kyosai Hospital
🇯🇵
Kanagawa, Japan
Prince of Wales Hospital
🇭🇰
Hong Kong, Hong Kong
Sir Run Run Shaw Hospital
🇨🇳
Hangzhou, China
The Second Affiliated Hospital of Xian Jiaotong University
🇨🇳
Xi'an, China
Kokura Memorial Hospital
🇯🇵
Kitakyushu-shi, Fukuoka, Japan
University of Tsukuba Hospital
🇯🇵
Tsukuba, Ibaraki, Japan
Kyoto University Hospital
🇯🇵
Kyoto, Japan
Saga University Hospital
🇯🇵
Saga, Japan
Kitasato University Hospital
🇯🇵
Sagamihara, Japan
Kyorin University Hospital
🇯🇵
Tama, Japan
Taipei Veterans General Hospital (VGH)
🇨🇳
Taipei City, Taiwan
Ogaki Municipal Hospital
🇯🇵
Ōgaki, Japan
Kaohsiung Chang Gung Memorial Hospital
🇨🇳
Kaohsiung City, Taiwan