Health Condition 1: I480- Paroxysmal atrial fibrillation Health Condition 2: I481- Persistent atrial fibrillation
Conditions
Interventions
Intervention1: Inquiryâ?¢ AFocusIIâ?¢ Double Loop catheter and HD Mapping Catheter: Inquiryâ?¢ AFocusâ?¢ diagnostic catheters are steerable flexible insulated electrophysiology catheters constructed o
Sponsors
St Jude Medical Abbott
Eligibility
Inclusion 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: 3.1 Documented symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within 7 days of onset 3.2 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
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 investigatorâ??s opinion, could limit the subjectâ??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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To quantify & characterize acute/long-term success rate as proportion of subjects who receive HD-mapping & RF energy delivery: -Resulting in acute termination of clinical arrhythmia (i.e. termination to SR or non-inducibility of clinical arrhythmia): â??acute successâ?? -Freedom from all atrial arrhythmias (documented by 24-hr Holter at 1-year visit) of greater than 30sec + on/off or off all class-I/III AADs: â??long-term successâ?? (Post procedure 90-day blanking period)Timepoint: 1-Month, 6-Month and 12-Month post procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Ablation strategy(s) used: defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians ablation strategy and the frequency each ablation strategy/target was used by physiciansTimepoint: At procedure;Adverse events including any device-, procedure-, or death-related eventsTimepoint: At all visits;Change in quality of life (QOL) at 6 months and 12 months after receiving HD mapping and RF ablation relative to baseline: defined as change in quality of life assessed in the validated EQ-5D-5L QOL survey.Timepoint: 6-month and 12-month;Fluoroscopy time: defined as total time subject is exposed to fluoroscopyTimepoint: At procedure;Mapping time associated with mapping arrhythmia: 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)Timepoint: At procedure;Number of mapping points collected: defined as total number of mapping points collected for the creation of each mapTimepoint: At procedure;Number of mapping points used: defined as the total number of mapping points used in each mapTimepoint: At procedure;Number of used mapping points per minute: defined as the total number of mapping points used divided by the relative mapping timeTimepoint: At procedure;Overall procedure time: defined as time from initial catheter insertion to final catheter removal.Timepoint: At procedure;Radiofrequency (RF) time: defined as duration of time RF energy is deliveredTimepoint: At procedure;Rate of repeat ablations after study procedure during 12-month follow up defined as proportion of subjects without an additional ablation procedure to treat indicated cardiac arrhythmia (outside blanking period, if applicable).Timepoint: Pre-discharge, 6-month and 12-month;Substrate characteristics identified: for each type of arrhythmogenic substrate this will be defined as the frequency of substra | — |
Countries
China, Hong Kong, India, Japan, Malaysia, Taiwan
Contacts
Public ContactDr Sumit Anand
St. Jude Medical (Abbott)
Outcome results
None listed