Advisor HD Grid Observational Study

The rate of acute success is defined as the percent of subjects who received HD Grid mapping and RF energy delivery according to label resulting in acute termination of clinical arrhythmia, defined by termination to sinus rhythm (SR) (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt).

For PersAF, the rate of long-term success rate is defined as the percent of subjects who receive HD Grid mapping and RF energy delivery according to label and have had freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 48-hr Holter at 12-month follow-up) and a new or increased dose in class I/III antiarrhythmic drug (AAD). For VT, the percent of subjects who receive HD Grid mapping and RF energy delivery according to label and have had freedom from recurrence of sustained monomorphic VT and a new or increase dose in class I/III AAD at 6-month follow-up. The percent of subjects who are free from the pre-defined endpoints on or off class I/III AADs is also reported.

Overall procedure time is defined as time from initial catheter insertion to final catheter removal.

Defined as duration of time RF energy is delivered

Defined as total time subject is exposed to fluoroscopy

Defined as the total mapping time for the creation of each map (including any new or retrospective map created with Manual, AutoMap, and TurboMap mapping)

Defined as total number of mapping points collected for the creation of each map.

Defined as the total number of mapping points used divided by the relative mapping time

For each type of arrhythmogenic substrate this will be defined as the frequency of substrate type identified in cases that attempted to identify the specific substrate.

Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians.

Assessed by physician survey comparing maps generated with HD Wave electrode configuration to along-the-spline (standard) electrode configurations.

Defined as the ability to maneuver the HD Grid to each specified anatomic location if attempted, the ability to contact cardiac tissue, and the incidence of induced ectopic beats during maneuvering.

Defined as the proportion of electrograms collected with HD Grid that have better quality/less noise than electrograms collected with the ablation catheter at the same cardiac location as assessed by physician survey.

Defined by the frequency each ablation strategy/target was used by physicians to treat those indicated for PersAF

Pulmonary vein isolation (PVI) Right Superior Pulmonary Vein (RSPV) Right Inferior Pulmonary Vein (RIPV) Left Superior Pulmonary Vein (LSPV) Left Inferior Pulmonary Vein (LIPV)

Defined by the frequency each ablation strategy/target was used by physicians to treat those indicated for VT.

Number of subjects in whom the HD Grid is inserted and experienced periprocedural and immediate post procedural (48hrs) procedure- or device- related adverse events.

Number of subjects in whom the HD Grid is inserted and experienced procedure- or device-related adverse events and cardiovascular serious adverse events between 48 hours and 30 days post-procedure.

Defined as the proportion of subjects free from an additional ablation procedure to treat indicated cardiac arrhythmia (after a blanking period of 90 days) out of the subjects who received HD Grid mapping and RF energy delivery, and either completed 12 months of follow up or did not complete 12 months of follow up but experienced a repeat ablation before withdrawing from the study (PersAF subjects).

Defined as the proportion of subjects free from an additional ablation procedure to treat indicated cardiac arrhythmia (after a blanking period of 14 days) out of the subjects who received HD Grid mapping and RF energy delivery, and either completed 6 months of follow up or did not complete 6 months of follow up but experienced a repeat ablation before withdrawing from the study (VT subjects), excluding subjects in which a device was used off-label.

Quality of life (QOL) validated by EQ-5D-5L and Atrial Fibrillation Effect on Quality-of-Life (AFEQT) in PersAF subjects at Baseline, 6 and 12 months after receiving HD Grid mapping and RF ablation.

The visual analogue score (VAS) component of the EQ-5D-5L questionnaire indicate how good or bad a subject's health was on the day the questionnaire was administered. 100 means the best health you can imagine and 0 means the worst health you can imagine.

There are 4 subscales that contribute to the Overall AFEQT Score (Symptoms, Daily Activities, Treatment Concern, and Treatment Satisfaction). The overall AFEQT score is calculated using the first 3 domains and ranges from 0 = worst to 100 = best QoL. Patient satisfaction with treatment is not considered to be a part of a patient's health status and is not included in the summary score calculation.

Quality of Life validated by EQ-5D-5L survey in VT subjects at Baseline, 6 and 12 months after receiving HD Grid mapping and RF ablation. Higher scores mean a better outcome.

The visual analogue score (VAS) component of the EQ-5D-5L questionnaire indicate how good or bad a subject's health was on the day the questionnaire was administered. 100 means the best health you can imagine and 0 means the worst health you can imagine.

Quality of Life validated by Hospitalization Anxiety and Depression Scale (HADS) survey in VT subjects at Baseline, 6 and 12 months after receiving HD Grid mapping and RF ablation. Percent of subjects scoring in the Normal, Borderline Abnormal, and Abnormal ranges in Anxiety and Depression categories.

Each question on the HADS questionnaire is on a scale of 0-3. 0 mean no anxiety/depression and 3 means high anxiety and depression. All question scores are totaled for a range of 0-21. 0-7 score indicates normal levels of anxiety/depression, 8-10 indicates borderline abnormal anxiety/depression, and 11-21 indicated and abnormal case of anxiety/depression.

Long-term success is defined as the percent of VT subjects who receive HD Grid mapping and RF energy delivery and have had freedom from recurrence of sustained monomorphic VT and a new or increase dose in class I/III AAD at 12-month follow-up. The percent of subjects who are free from the pre-defined endpoints on or off class I/III AADs is also reported.