Condition or disease | Intervention/treatment |
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Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation | Device: Catheter ablation |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 200 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 12 Months |
Official Title: | HD Mapping Observational Study - Asia Pacific |
Actual Study Start Date : | September 11, 2019 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | April 2022 |
Group/Cohort | Intervention/treatment |
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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.
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Device: Catheter ablation
Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled
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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.
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Device: Catheter ablation
Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled
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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Subject is diagnosed with AF as defined by:
Exclusion Criteria:
China | |
Sir Run Run Shaw Hospital | |
Hangzhou, China | |
The Second Affiliated Hospital of Xian Jiaotong University | |
Xi'an, China | |
Hong Kong | |
Prince of Wales Hospital | |
Hong Kong, Hong Kong | |
Japan | |
Kokura Memorial Hospital | |
Kitakyushu-shi, Fukuoka, Japan, 802-8555 | |
University of Tsukuba Hospital | |
Tsukuba, Ibaraki, Japan, 305-8576 | |
Yokosuka Kyosai Hospital | |
Kanagawa, Japan | |
Kyoto University Hospital | |
Kyoto, Japan, 606-8507 | |
Kitasato University Hospital | |
Sagamihara, Japan | |
Saga University Hospital | |
Saga, Japan | |
Kyorin University Hospital | |
Tama, Japan | |
Ogaki Municipal Hospital | |
Ōgaki, Japan | |
Korea, Republic of | |
Korea University Anam Hospital | |
Seoul, Korea, Republic of | |
Severance Hospital | |
Seoul, Korea, Republic of | |
Taiwan | |
Kaohsiung Chang Gung Memorial Hospital | |
Kaohsiung City, Taiwan | |
Taipei Veterans General Hospital (VGH) | |
Taipei City, Taiwan |
Study Director: | Kristin Ruffner, PhD | EP Program Director |
Tracking Information | |||||||
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First Submitted Date | June 29, 2019 | ||||||
First Posted Date | July 17, 2019 | ||||||
Last Update Posted Date | October 8, 2020 | ||||||
Actual Study Start Date | September 11, 2019 | ||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
Acute- and long-term success rate of RF ablation after electroanatomical mapping with HD mapping catheters. [ Time Frame: 12-months post-procedure ] The rate of acute success 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). The rate of long-term success defined as the proportion of subjects who receive HD mapping and RF energy delivery with pre-defined procedural endpoints: AF 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 antiarrhythmic drug (AAD). AF 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.
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||||
Brief Title | HD Mapping of Atrial Fibrillation in Asia Pacific | ||||||
Official Title | HD Mapping Observational Study - Asia Pacific | ||||||
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 Provided | ||||||
Study Type | Observational [Patient Registry] | ||||||
Study Design | Observational Model: Other Time Perspective: Prospective |
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Target Follow-Up Duration | 12 Months | ||||||
Biospecimen | Not Provided | ||||||
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 | ||||||
Condition |
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Intervention | Device: Catheter ablation
Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Active, not recruiting | ||||||
Actual Enrollment |
200 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | April 2022 | ||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 99 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | China, Hong Kong, Japan, Korea, Republic of, Taiwan | ||||||
Removed Location Countries | India | ||||||
Administrative Information | |||||||
NCT Number | NCT04022954 | ||||||
Other Study ID Numbers | CRD975 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Abbott Medical Devices | ||||||
Study Sponsor | Abbott Medical Devices | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Abbott Medical Devices | ||||||
Verification Date | October 2020 |