Study Results
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View full resultsBasic Information
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COMPLETED
200 participants
OBSERVATIONAL
2019-09-11
2021-08-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
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.
Catheter ablation
Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled
Interventions
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Catheter ablation
Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
99 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Kristin Ruffner, PhD
Role: STUDY_DIRECTOR
EP Program Director
Locations
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Sir Run Run Shaw Hospital
Hangzhou, , China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, , China
Prince of Wales Hospital
Hong Kong, , Hong Kong
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Yokosuka Kyosai Hospital
Kanagawa, , Japan
Kyoto University Hospital
Kyoto, , Japan
Ogaki Municipal Hospital
Ōgaki, , Japan
Saga University Hospital
Saga, , Japan
Kitasato University Hospital
Sagamihara, , Japan
Kyorin University Hospital
Tama, , Japan
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Taipei Veterans General Hospital (VGH)
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CRD975
Identifier Type: -
Identifier Source: org_study_id
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