Atrial fibrillation heart rhythm disorder
Conditions
Interventions
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Presence of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT) referred for catheter ablation 2. Age of 18 years of age or older at time of Enrollment 3. On continuous anticoagulation (INR 2-3) for >4 weeks prior to the ablation 4. Able and willing to provide written informed consent to participate in this clinical investigation
Exclusion criteria
Exclusion criteria: 1. Secondary atrial fibrillation (AF) 2. Presence of a prosthetic valve(s) or hemodynamically significant valvular heart disease as determined by Study Investigator 3. Active systemic infection (e.g. sepsis) 4. Presence of left atrial thrombus (i.e., positive TEE) or myxoma, or interatrial baffle or patch via the transseptal approach 5. Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor) 6. History of cerebrovascular accidents (Stroke, TIA) 7. Previous myocardial infarction, unstable angina pectoris or coronary artery by-pass 55mm 9. NYHA functional class III or IV heart failure 10. Left ventricular ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoint: the proportion of subjects who experience intra-procedure and/or post-procedure serious adverse events within 48 hours from the mapping procedure. Feasibility Endpoints: * Determination of atrial areas with fast and regular activities in the left atrium will be summarized by the proportion of subjects with each of the following arrhythmia location: coronary sinus, LA appendage, posterior wall, roof, mitral isthmus, left superior pulmonary vein, right superior pulmonary vein, left inferior pulmonary vein, right inferior pulmonary vein, septum, and any other location that was mapped. Performance Endpoints: * Geometry creation will be assessed by: o The HD Grid Catheter*s ability to be maneuvered to all desired anatomic locations, o The incidence of induced ectopic beats or other arrhythmias occurring during HD Grid Catheter maneuvering, o The HD Grid Catheters ability to contact cardiac tissue, o Determination if field scaling is appropriate when using the HD Grid Catheter o Geometry created with the HD Grid Catheter is comparable to the subjects CT/MRI (if CT/MRI is available) | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility endpoints: * Determination of atrial areas with fast and regular activities in the right atrium will be summarized by the proportion of subjects with each of the following arrhythmia locations: anterior wall, appendage, posterior wall, roof, septum, other. Additionally, the average (+/- standard deviation) of the cycle length for each location will be summarized. * Complex fractionated electrograms will be summarized as the proportion of subjects in whom a complex fractionated electrogram (defined as electrograms that have low peak-to-peak amplitude and a cycle length of * 120 ms) was identified. * Consistent direction of wave front propagation will be summarized by the average and standard deviation of the number of map points, the conduction velocity and activation duration. Performance endpoints: * Map repeatability will be characterized by evaluating substrate conduction velocity maps created using the HD Grid Catheter mapping system pre-ablation compared to repeat pre-ablation. * Demonstrate that the post-ablation map created with the HD Grid Catheter shows a change corresponding to the ablation result (i.e. sinus rhythm) * The HD Grid Catheter electrogram signals will be assessed by: o The proportion of electrograms collected with the HD Grid Catheter that have better quality/less noise than electrograms collected with the ablation catheter at the same selected cardiac location o The proportion of electrogram wave form traces from the HD Grid Catheter that could be used to help diagnose the subject Other secundairy endpoints * Total mapping time * retrospective analysis * Number of map points collected * retrospective analysis * Number of RF ablations * from the Ampere generator * retrospective analysis * Total RF application time * from the Ampere generator * retrospective analysis * Occurrence of repeat ablations (incidence and time from index procedure) * Incidence of all SAEs up to and including the 6 month follow | — |
Countries
Australia, France, Germany, Hong Kong, Italy, Netherlands, United Kingdom
Outcome results
None listed