Persistent Atrial Fibrillation
Conditions
Brief summary
The purpose of this feasibility study is to further explore characteristics of ablation targets identified by CARTOFINDER 4D LAT Algorithm in subjects with persistent atrial fibrillation and to assess the acute outcome of CARTOFINDER Guided Ablation in terms of the termination of atrial fibrillation to either Normal Sinus Rhythm or Atrial Tachycardia.
Interventions
DEVICEAblation procedure
All enrolled subjects who have ablation targets identified will undergo CARTOFINDER guided ablation (CFGA) followed by PVI. Subjects will be followed per the protocol schedule. Subjects who have no ablation target identified on the baseline CARTOFINDER map will undergo ablation per the institution's standard of care and be followed for 7 days for safety monitoring, then exit from the study.
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet the following inclusion criteria: 1. Age \> 18 years. 2. Patients who have signed the Patient Informed Consent Form (ICF) 3. Scheduled to undergo a clinically-indicated catheter ablation procedure for treatment of persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond seven consecutive days). 3.1. Drug-refractory atrial fibrillation. (failed 1 or more class I or III antiarrhythmic drugs) and demonstrating Persistent AF (requiring drugs or electrical shock to terminate) 4. Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patients not confined by a court ruling)
Exclusion criteria
Subject who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate mapping characteristics | Intraoperative | Explore characteristics of ablation targets identified by the CARTOFINDER 4D LAT Algorithm |
| Evaluate acute safety of freedom from procedure-related primary adverse events | Within 7 days | Evaluate acute safety of freedom from procedure-related primary adverse events occurring within 7 days of ablation procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate atrial fibrillation (AF) termination | Perioperative | Evaluate the AF termination to Normal Sinus Rhythm (NSR) or an Atrial Tachycardia (AT) after CARTOFINDER™ Guided Ablation (CFGA) of identified ablation target and after PVI |
Outcome results
None listed