Status:
COMPLETED
HD Mapping of Atrial Fibrillation in Asia Pacific
Lead Sponsor:
Abbott Medical Devices
Conditions:
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-99 years
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 In...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 13 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04022954
Start Date
September 11 2019
End Date
August 13 2021
Last Update
March 29 2024
Active Locations (15)
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1
Sir Run Run Shaw Hospital
Hangzhou, China
2
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, China
3
Prince of Wales Hospital
Hong Kong, Hong Kong
4
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, Japan, 802-8555