arrhythmia atrial fibrillation (PersAF) or ventricular tachycardia (VT)
Conditions
Interventions
None listed
Sponsors
Abbott
Eligibility
Age
18 Years to 99 Years
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. Over 18 years of age 3. Indicated for cardiac electroanatomical mapping and RF ablation procedure to treat PersAF or VT 4. Subject is diagnosed with either PersAF OR VT as defined by: a. Persistent AF
Exclusion criteria
Exclusion criteria: 1. Life expectancy less than 12 months 2. Women who are pregnant or nursing 3. Known intracardiac thrombus or myxoma verified within 48 hours of index ablation procedure 4. Myocardial infarction (MI) or unstable angina, or previous cardiac surgery within 60 days of index ablation procedure 5. Percutaneous coronary intervention (PCI) within 30 days of index ablation procedure 6. Documented cerebroembolic event within the past 12 months (365 days) 7. History of valve repair, presence of a prosthetic valve, or severe mitral regurgitation thought to require valve replacement or repair within 12 months 8. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days) 9. Current acute illness or active systemic infection or sepsis 10. Currently enrolled in another clinical study that could confound the results of this study 11. Any cause for contraindication to ablation procedure or systemic anticoagulation 12. 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 study or to comply with follow-up requirements, or impact the scientific soundness of the clinical study results. 13. Vulnerable patient or individuals whose willingness to volunteer in a study, in the judgement of investigator or public authorities, could be unduly influenced by lack of or loss of autonomy 14. Indication-specific exclusion criteria including: a. PersAF: i. PersAF felt to be secondary to electrolyte imbalance, uncontrolled thyroid disease, or reversible or non-cardiac cause. ii. Prior catheter ablation for AF beyond pulmonary vein isolation iii. LAD > 55 mm (parasternal long axis view) iv. LVEF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To quantify and characterize the acute- and long-term success rate of RF ablation after electroanatomical mapping with HD Grid, the following will be summarized: * Rate of acute success defined as the proportion of subjects who receive HD Grid mapping and RF energy delivery resulting in acute termination of clinical arrhythmia. * Rate of long-term success defined as the proportion of subjects who receive HD Grid mapping and RF energy delivery with the following pre-defined procedural endpoints: Persistent AF : o freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 48-hr Holter at 12-month follow-up) and new or increased dose of class I/III antiarrhythmic drug (AAD). o freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 48-hr Holter at 12-month follow-up) on or off class I/III AAD. VT : o freedom from recurrence of sustained monomorphic VT and new or increased dose of class I/III AAD at 6-month follow-up o freedom from recurrence of sustained monomorphic VT on or off class I/III AAD at 6-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The second objective is to quantify and characterize the use of HD Grid and EnSite Precision with HD Wave in the electroanatomical mapping of PersAF or VT in real-world clinical settings. This will be done through a summary of the following: Use of HD Grid and EnSite Precision with HD Wave will be quantified and characterized through the summary of the following: * Overall procedure time: defined as time from initial catheter insertion to final catheter removal. * Radiofrequency (RF) time: defined as duration of time RF energy is delivered * Fluoroscopy time: defined as total time subject is exposed to fluoroscopy * Mapping time associated with mapping arrhythmia: * Number of mapping points collected: * Number of mapping points used: * Number of used mapping points per minute: * Substrate characteristics identified: * Ablation strategy(s) used: * Role of HD Wave map relative to along-the-spline map in ablation strategy decision: as assessed by physician survey comparing maps generated with HD Wave electrode configuration to along-the-spline electrode configurations. * Maneuverability of HD Grid catheter: * HD Grid electrogram quality relative to ablation catheter electrograms: as assessed by physician survey | — |
Countries
Netherlands
Outcome results
None listed