Clinical trial NCT04022954: HD Mapping of Atrial Fibrillation in Asia Pacific
Official title: HD Mapping Observational Study - Asia Pacific
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-07-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Number of Participants With Acute Success of RF Ablation After Electroanatomical Mapping With HD Mapping Catheters.
timeFrame: End of Procedure
measure: Number of Participants With Clinical Long-Term Success
timeFrame: 12 months post-procedure
measure: Number of Participants With AAD-Free Long-Term Success
timeFrame: 12-month post-procedure
Secondary outcomes:
measure: Overall Procedure Time
timeFrame: During Procedure
measure: Radiofrequency (RF) Time
timeFrame: During Procedure
measure: Fluoroscopy Time
timeFrame: During Procedure
measure: Mapping Time Associated With Mapping Arrhythmia
timeFrame: During Procedure
measure: Number of Mapping Points Collected
timeFrame: During Procedure
measure: Number of Mapping Points Used
timeFrame: During Procedure
measure: Number of Used Mapping Points Per Minute
timeFrame: During Procedure
measure: Substrate Characteristics Identified
timeFrame: During Procedure
measure: Ablation Strategy(s) Used
timeFrame: During Procedure
Other outcomes:
measure: Number of Participants With Adverse Events
timeFrame: through study completion, an average of 1 year
measure: Number of Subjects With Repeat Ablations
timeFrame: 12-months post-procedure
measure: Change in Quality of Life (QoL): EQ-5D-5L VAS Score
timeFrame: 12-months post-procedure
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xian Jiaotong University
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Kitakyushu-shi
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Kanagawa
country: Japan
facility: Yokosuka Kyosai Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
city: Saga
country: Japan
facility: Saga University Hospital
city: Tama
country: Japan
facility: Kyorin University Hospital
city: Ōgaki
country: Japan
facility: Ogaki Municipal Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital (VGH)
Study officials:
affiliation: EP Program Director
name: Kristin Ruffner, PhD
role: STUDY_DIRECTOR
References: