Persistent Atrial Fibrillation, Ventricular Tachycardia
Conditions
Brief summary
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of electroanatomical mapping with the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (hereafter called HD Grid) and EnSite Precision™ Cardiac Mapping System (SV 2.2 or higher, hereafter called EnSite Precision) with HD Wave Solution™ voltage mapping (hereafter called HD Wave Solution) in subjects with persistent atrial fibrillation (PersAF) or ventricular tachycardia (VT) in real-world clinical settings.
Interventions
DEVICEAdvisor HD Grid Mapping Catheter, Sensor Enabled
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Sponsors
Abbott Medical Devices
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: i. Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months b. VT: i. Sustained monomorphic ventricular tachycardia with record of VT event within last 6 months and history of prior myocardial infarction
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 cerebro-embolic 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Subjects With Acute Success | Immediate post procedure | 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). |
| Rate of Subjects With Long-term Success | PersAF (12 months), VT (6-months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Mapping Points Collected | During Procedure | Defined as total number of mapping points collected for the creation of each map. |
| Substrate Characteristics Identified | During Procedure | 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. |
| Map Type Used to Define Ablation Strategy | During Procedure | Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians. |
| Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | During Procedure | Assessed by physician survey comparing maps generated with HD Wave electrode configuration to along-the-spline (standard) electrode configurations. |
| Maneuverability of HD Grid Catheter | During Procedure | 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. |
| HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | During Procedure | 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. |
| Ablation Strategy(s) Used for PersAF Subjects | During Procedure | 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) |
| Ablation Strategy(s) Used for VT Subjects | During the Procedure | Defined by the frequency each ablation strategy/target was used by physicians to treat those indicated for VT. |
| Overall Procedure Time | During procedure | Overall procedure time is defined as time from initial catheter insertion to final catheter removal. |
| Radiofrequency (RF) Time | During Procedure | Defined as duration of time RF energy is delivered |
| Fluoroscopy Time | During Procedure | Defined as total time subject is exposed to fluoroscopy |
| Mapping Time Associated With Mapping Arrhythmia | During Procedure | 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) |
| Number of Used Mapping Points Per Minute | During Procedure | Defined as the total number of mapping points used divided by the relative mapping time |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life: EQ-5D-5L Visual Analog Scale Scores and AFEQT Overall Scores in PersAF Subjects | Baseline, 6 months, 12 months | 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: EQ-5D-5L Visual Analog Scale Scores in VT Subjects | Baseline, 6 months, 12 months | 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. |
| Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Baseline, 6 months, and 12 months | 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 in VT Subjects at 12 Months | 12 months | 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. |
| Rate of Procedure- or Device-related Adverse Events and Cardiovascular Serious Adverse Events in All Subjects in Whom the HD Grid is Inserted . | 48 hours - 30 days | 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. |
| Incidence of Periprocedural and Immediate Post Procedural (48hrs) Procedure- or Device- Related Adverse Events in All Subjects in Whom the HD Grid is Inserted. | 48 hours | Number of subjects in whom the HD Grid is inserted and experienced periprocedural and immediate post procedural (48hrs) procedure- or device- related adverse events. |
| Rate of Subjects Free From Repeat Ablations After Study Procedure During 12-month Follow up | Through 12 months | 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. |
Countries
Australia, Austria, Canada, Denmark, France, Germany, Italy, Netherlands, Portugal, South Africa, Spain
Participant flow
Pre-assignment details
372 of the 379 enrolled subjects started and completed the ablation procedure. The remaining 7 subjects (5 PersAF, 2 VT) were withdrawn prior to procedure due to presence of thrombus, mapping system incompatible with the HD Grid, subject withdrawal of consent, and/or early enrollment closure.
Participants by arm
| Arm | Count |
|---|---|
| PersAF Subjects Enrolled subjects who provided written informed consent, confirmed to meet all inclusion criteria and none of the exclusion criteria, indicated for cardiac electroanatomical mapping and RF ablation procedure to treat persistent atrial fibrillation, and in which the HD Grid catheter was inserted and RF ablation procedure performed. | 334 |
| VT Subjects Enrolled subjects who provided written informed consent, confirmed to meet all inclusion criteria and none of the exclusion criteria, indicated for cardiac electroanatomical mapping and RF ablation procedure to treat sustained monomorphic ventricular tachycardia, and in which the HD Grid catheter was inserted and RF ablation procedure performed. | 38 |
| Total | 372 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Inclusion/Exclusion Criteria Not Met or Non-eligibility | 4 | 4 |
| Overall Study | Incomplete Ablation or Ablation not done | 0 | 5 |
| Overall Study | Lost to Follow-up | 5 | 0 |
| Overall Study | Patient Non-Compliance | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Subject did not complete follow-up but did not meet criteria for lost-to-follow-up | 12 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 1 |
| Overall Study | Withdrawal prior to procedure | 5 | 2 |
Baseline characteristics
| Characteristic | PersAF Subjects | Total | VT Subjects |
|---|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 10.4 | 64.1 years STANDARD_DEVIATION 10.7 | 64.0 years STANDARD_DEVIATION 13.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Australia | 36 participants | 43 participants | 7 participants |
| Region of Enrollment Austria | 73 participants | 75 participants | 2 participants |
| Region of Enrollment Canada | 24 participants | 25 participants | 1 participants |
| Region of Enrollment Denmark | 2 participants | 2 participants | 0 participants |
| Region of Enrollment France | 59 participants | 63 participants | 4 participants |
| Region of Enrollment Germany | 72 participants | 76 participants | 4 participants |
| Region of Enrollment Italy | 9 participants | 10 participants | 1 participants |
| Region of Enrollment Netherlands | 15 participants | 15 participants | 0 participants |
| Region of Enrollment Portugal | 3 participants | 3 participants | 0 participants |
| Region of Enrollment South Africa | 36 participants | 47 participants | 11 participants |
| Region of Enrollment Spain | 5 participants | 13 participants | 8 participants |
| Sex: Female, Male Female | 80 Participants | 86 Participants | 6 Participants |
| Sex: Female, Male Male | 254 Participants | 286 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 334 | 0 / 38 |
| other Total, other adverse events | 10 / 334 | 0 / 38 |
| serious Total, serious adverse events | 39 / 334 | 11 / 38 |
Outcome results
Primary
Rate of Subjects With Acute Success
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).
Time frame: Immediate post procedure
Population: PersAF: Subjects indicated for ablation to treat PersAF in which the HD grid catheter was inserted, and RF energy was applied according to label.~VT: Subjects indicated for ablation to treat VT in which the HD grid catheter was inserted, and RF energy was applied according to label.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PersAF Subjects | Rate of Subjects With Acute Success | 287 Participants |
| VT Subjects | Rate of Subjects With Acute Success | 14 Participants |
Primary
Rate of Subjects With Long-term Success
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.
Time frame: PersAF (12 months), VT (6-months)
Population: PersAF: Subjects indicated for ablation to treat PersAF in which the HD grid catheter was inserted, and RF energy was applied according to label who completed their 12-month follow-up visit.~VT: Subjects indicated for ablation to treat VT in which the HD grid catheter was inserted, and RF energy was applied according to label who completed their 6-month follow-up visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PersAF Subjects | Rate of Subjects With Long-term Success | Freedom from arrhythmia recurrence and new or increased dose of class I/III AAD | 168 Participants |
| PersAF Subjects | Rate of Subjects With Long-term Success | Freedom from arrhythmia recurrence on or off class I/III AAD | 173 Participants |
| VT Subjects | Rate of Subjects With Long-term Success | Freedom from arrhythmia recurrence and new or increased dose of class I/III AAD | 14 Participants |
| VT Subjects | Rate of Subjects With Long-term Success | Freedom from arrhythmia recurrence on or off class I/III AAD | 14 Participants |
Secondary
Ablation Strategy(s) Used for PersAF Subjects
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)
Time frame: During Procedure
Population: PersAF subjects who received electroanatomical mapping with Advisor HD Grid for which ablation strategy data was available, excluding subjects in which a device was used off-label.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | PVI (RSPV) | 174 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | PVI (RIPV) | 168 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | PVI (Common Right) | 132 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | PVI (LSPV) | 145 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | PVI (LIPV) | 143 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | PVI (Common Left) | 147 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Roof | 66 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Posterior Wall Isolation | 41 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Cavo tricuspid isthmuc | 38 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Mitral Isthmus | 36 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Complex Fractionated Electrograms (CFE) | 25 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Box Isolation of Fibrotic Area | 16 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Left Atrial Appendage (LAA) Focal Ablation | 9 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Coronary Sinus | 9 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Superior Vena Cava Isolation | 8 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Other | 6 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Crista Terminalis | 5 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Eustachian Ridge | 2 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | LAA Isolation | 1 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Fossa Ovalis | 1 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for PersAF Subjects | Ligament of Marshall | 1 Participants |
Secondary
Ablation Strategy(s) Used for VT Subjects
Defined by the frequency each ablation strategy/target was used by physicians to treat those indicated for VT.
Time frame: During the Procedure
Population: VT subjects who received electroanatomical mapping with Advisor HD Grid for which ablation strategy data was available, excluding subjects in which a device was used off-label.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PersAF Subjects | Ablation Strategy(s) Used for VT Subjects | Late Potential in Scar | 15 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for VT Subjects | Low Voltage in Scar | 9 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for VT Subjects | Regions of Pace-match | 9 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for VT Subjects | Dechanneling exit site | 7 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for VT Subjects | Fibrotic Areas | 2 Participants |
| PersAF Subjects | Ablation Strategy(s) Used for VT Subjects | Scar Homogenization | 0 Participants |
Secondary
Fluoroscopy Time
Defined as total time subject is exposed to fluoroscopy
Time frame: During Procedure
Population: PersAF: Subjects indicated for ablation to treat PersAF for which fluoroscopy time data was available, excluding subjects in which a device was used off-label.~VT: Subjects indicated for ablation to treat VT for which fluoroscopy time data was available, excluding subjects in which a device was used off-label.~AFL: PersAF-indicated subjects also treated for AFL for which fluoroscopy time data was available, excluding subjects in which a device was used off-label.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PersAF Subjects | Fluoroscopy Time | 14.5 minutes | Standard Deviation 11.3 |
| VT Subjects | Fluoroscopy Time | 31.3 minutes | Standard Deviation 17.4 |
| AFL Subjects | Fluoroscopy Time | 13.7 minutes | Standard Deviation 10.6 |
Secondary
HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms
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.
Time frame: During Procedure
Population: PersAF: Subjects indicated for ablation to treat PersAF for which electrogram signal quality data was available, excluding subjects in which a device was used off-label.~VT: Subjects indicated for ablation to treat VT for which electrogram signal quality data was available, excluding subjects in which a device was used off-label.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PersAF Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | HD Grid electrogram quality/noise vs. ablation catheters at same cardiac location - Much Better | 93 Participants |
| PersAF Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | HD Grid electrogram quality/noise vs. ablation catheters at same cardiac location - About the same | 30 Participants |
| PersAF Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | HD Grid identified signals of interest not identified with ablation catheter | 205 Participants |
| PersAF Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | HD Grid electrogram quality/noise vs. ablation catheters at same cardiac location - Worse | 0 Participants |
| PersAF Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | HD Grid electrogram quality/noise vs. ablation catheters at same cardiac location - Better | 130 Participants |
| PersAF Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | HD Grid electrogram quality/noise vs. ablation catheters at same cardiac location - Much Worse | 0 Participants |
| PersAF Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | Electrogram signals assessed for quality/noise compared to ablation catheter | 255 Participants |
| VT Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | HD Grid electrogram quality/noise vs. ablation catheters at same cardiac location - Much Worse | 0 Participants |
| VT Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | Electrogram signals assessed for quality/noise compared to ablation catheter | 15 Participants |
| VT Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | HD Grid identified signals of interest not identified with ablation catheter | 14 Participants |
| VT Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | HD Grid electrogram quality/noise vs. ablation catheters at same cardiac location - Much Better | 6 Participants |
| VT Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | HD Grid electrogram quality/noise vs. ablation catheters at same cardiac location - Better | 9 Participants |
| VT Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | HD Grid electrogram quality/noise vs. ablation catheters at same cardiac location - About the same | 0 Participants |
| VT Subjects | HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms | HD Grid electrogram quality/noise vs. ablation catheters at same cardiac location - Worse | 0 Participants |
Secondary
Maneuverability of HD Grid Catheter
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.
Time frame: During Procedure
Population: PersAF: Subjects indicated for ablation to treat PersAF for which HD Grid maneuverability data was available, excluding subjects in which a device was used off-label.~VT: Subjects indicated for ablation to treat VT for which HD Grid maneuverability data was available, excluding subjects in which a device was used off-label..
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PersAF Subjects | Maneuverability of HD Grid Catheter | Difficult reaching a specific area of the heart with HD Grid | 70 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Attempted to make contact with cardiac wall | 333 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Sufficient contact all of the time (100%) | 67 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Sufficient contact most of the time (91-99%) | 233 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Sufficient contact some of the time (52-90%) | 33 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Sufficient contact occasionally (11-50%) | 0 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Sufficient contact rarely (0-10%) | 0 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Difficulty reaching Left Atrium | 66 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Difficulty reaching Right Atrium | 4 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Difficulty reaching Left Ventricle | 0 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Difficulty reaching Right Ventricle | 1 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Attempted to maneuver HD Grid into the Pulmonary veins | 327 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Successful maneuvering into the Pulmonary veins | 325 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - None | 166 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - Minimal | 164 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - Half the time | 1 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - Most of the time | 2 Participants |
| PersAF Subjects | Maneuverability of HD Grid Catheter | Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - Contact tachycardia | 1 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - None | 2 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Difficulty reaching Left Ventricle | 7 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Attempted to make contact with cardiac wall | 20 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - Contact tachycardia | 1 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Sufficient contact all of the time (100%) | 0 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Difficulty reaching Right Ventricle | 1 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Sufficient contact most of the time (91-99%) | 5 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - Minimal | 14 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Sufficient contact some of the time (52-90%) | 15 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Attempted to maneuver HD Grid into the Pulmonary veins | 2 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Sufficient contact occasionally (11-50%) | 0 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - Most of the time | 0 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Sufficient contact rarely (0-10%) | 0 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Difficult reaching a specific area of the heart with HD Grid | 7 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Successful maneuvering into the Pulmonary veins | 2 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Difficulty reaching Left Atrium | 0 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - Half the time | 3 Participants |
| VT Subjects | Maneuverability of HD Grid Catheter | Difficulty reaching Right Atrium | 0 Participants |
Secondary
Mapping Time Associated With Mapping Arrhythmia
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)
Time frame: During Procedure
Population: Maps generated for subjects with procedures and Advisor HD Grid used as mapping catheter excluding subjects in which a device was used off-label.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PersAF Subjects | Mapping Time Associated With Mapping Arrhythmia | 12.8 minutes | Standard Deviation 8.8 |
| VT Subjects | Mapping Time Associated With Mapping Arrhythmia | 13.6 minutes | Standard Deviation 11.8 |
| AFL Subjects | Mapping Time Associated With Mapping Arrhythmia | 20.6 minutes | Standard Deviation 15.3 |
| Other | Mapping Time Associated With Mapping Arrhythmia | 7.3 minutes | Standard Deviation 5.6 |
Secondary
Map Type Used to Define Ablation Strategy
Defined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians.
Time frame: During Procedure
Population: Maps generated for subjects with procedures and Advisor HD Grid used as mapping catheter excluding subjects in which a device was used off-label.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| PersAF Subjects | Map Type Used to Define Ablation Strategy | Fractionation | 9 Maps |
| PersAF Subjects | Map Type Used to Define Ablation Strategy | Local Activation Time (LAT) | 47 Maps |
| PersAF Subjects | Map Type Used to Define Ablation Strategy | Peak-Negative | 3 Maps |
| PersAF Subjects | Map Type Used to Define Ablation Strategy | CFE Mean | 32 Maps |
| PersAF Subjects | Map Type Used to Define Ablation Strategy | Peak-to-Peak | 322 Maps |
| VT Subjects | Map Type Used to Define Ablation Strategy | CFE Mean | 0 Maps |
| VT Subjects | Map Type Used to Define Ablation Strategy | Fractionation | 1 Maps |
| VT Subjects | Map Type Used to Define Ablation Strategy | Peak-Negative | 0 Maps |
| VT Subjects | Map Type Used to Define Ablation Strategy | Local Activation Time (LAT) | 42 Maps |
| VT Subjects | Map Type Used to Define Ablation Strategy | Peak-to-Peak | 9 Maps |
| AFL Subjects | Map Type Used to Define Ablation Strategy | CFE Mean | 1 Maps |
| AFL Subjects | Map Type Used to Define Ablation Strategy | Peak-to-Peak | 24 Maps |
| AFL Subjects | Map Type Used to Define Ablation Strategy | Local Activation Time (LAT) | 13 Maps |
| AFL Subjects | Map Type Used to Define Ablation Strategy | Fractionation | 0 Maps |
| AFL Subjects | Map Type Used to Define Ablation Strategy | Peak-Negative | 0 Maps |
| Other | Map Type Used to Define Ablation Strategy | Fractionation | 0 Maps |
| Other | Map Type Used to Define Ablation Strategy | Local Activation Time (LAT) | 19 Maps |
| Other | Map Type Used to Define Ablation Strategy | Peak-to-Peak | 12 Maps |
| Other | Map Type Used to Define Ablation Strategy | CFE Mean | 0 Maps |
| Other | Map Type Used to Define Ablation Strategy | Peak-Negative | 0 Maps |
Secondary
Number of Mapping Points Collected
Defined as total number of mapping points collected for the creation of each map.
Time frame: During Procedure
Population: Maps generated for subjects with procedures and Advisor HD Grid used as mapping catheter excluding subjects in which a device was used off-label.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PersAF Subjects | Number of Mapping Points Collected | 10150.8 Mapping points collected | Standard Deviation 8390.4 |
| VT Subjects | Number of Mapping Points Collected | 10533.1 Mapping points collected | Standard Deviation 11282.8 |
| AFL Subjects | Number of Mapping Points Collected | 16496.2 Mapping points collected | Standard Deviation 17207.5 |
| Other | Number of Mapping Points Collected | 3902.5 Mapping points collected | Standard Deviation 4125 |
Secondary
Number of Used Mapping Points Per Minute
Defined as the total number of mapping points used divided by the relative mapping time
Time frame: During Procedure
Population: Maps generated for subjects with procedures and Advisor HD Grid used as mapping catheter excluding subjects in which a device was used off-label.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PersAF Subjects | Number of Used Mapping Points Per Minute | 203.2 Used Mapping Points/Minute | Standard Deviation 172 |
| VT Subjects | Number of Used Mapping Points Per Minute | 170.8 Used Mapping Points/Minute | Standard Deviation 157.5 |
| AFL Subjects | Number of Used Mapping Points Per Minute | 81.9 Used Mapping Points/Minute | Standard Deviation 50.7 |
| Other | Number of Used Mapping Points Per Minute | 180.1 Used Mapping Points/Minute | Standard Deviation 199.9 |
Secondary
Overall Procedure Time
Overall procedure time is defined as time from initial catheter insertion to final catheter removal.
Time frame: During procedure
Population: PersAF: Subjects indicated for ablation to treat PersAF for which overall procedure time data was available, excluding subjects in which a device was used off-label.~VT: Subjects indicated for ablation to treat VT for which overall procedure time data was available, excluding subjects in which a device was used off-label.~AFL: PersAF-indicated subjects also treated for AFL for which overall procedure time data was available, excluding subjects in which a device was used off-label.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PersAF Subjects | Overall Procedure Time | 134.3 minutes | Standard Deviation 51.3 |
| VT Subjects | Overall Procedure Time | 174.1 minutes | Standard Deviation 54.2 |
| AFL Subjects | Overall Procedure Time | 171.4 minutes | Standard Deviation 60.3 |
Secondary
Radiofrequency (RF) Time
Defined as duration of time RF energy is delivered
Time frame: During Procedure
Population: PersAF: Subjects indicated for ablation to treat PersAF for which RF time data was available, excluding subjects in which a device was used off-label.~VT: Subjects indicated for ablation to treat VT for which RF time data was available, excluding subjects in which a device was used off-label.~AFL: PersAF-indicated subjects also treated for AFL for which RF time data was available, excluding subjects in which a device was used off-label.~AFL:
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PersAF Subjects | Radiofrequency (RF) Time | 32.0 minutes | Standard Deviation 23.2 |
| VT Subjects | Radiofrequency (RF) Time | 35.1 minutes | Standard Deviation 30.5 |
| AFL Subjects | Radiofrequency (RF) Time | 37.6 minutes | Standard Deviation 36.8 |
Secondary
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision.
Assessed by physician survey comparing maps generated with HD Wave electrode configuration to along-the-spline (standard) electrode configurations.
Time frame: During Procedure
Population: Analyzed maps with original electrode configuration as HD Wave Solution and comparable retrospective map generated in standard configuration
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave Solution compared to standard configuration | 187 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Worse | 4 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Ablation strategy identified with HD Wave Solution would have been different than standard | 31 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Surface Area of Low Voltage | 70 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Much Better | 26 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - About the Same | 61 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Better | 96 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Differences Identified - Overall | 117 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Preferred Map - Standard Configuration | 7 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Activation time/sequence | 4 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Fractionation | 33 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Preferred Map - HD Wave Solution Configuration | 150 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Presence of additional diagnostic signals | 1 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Preferred Map - No Preference | 30 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Other | 3 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Location of Low Voltage | 69 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Much Worse | 0 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Comparison during the procedure | 31 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave Solution assisted in selection/identification of ablation strategy | 18 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave Solution changed ablation strategy compared to standard configuration | 11 Maps |
| PersAF Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Comparison after the procedure | 156 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Fractionation | 1 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Comparison after the procedure | 20 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Preferred Map - Standard Configuration | 1 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave Solution compared to standard configuration | 24 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Preferred Map - No Preference | 8 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Ablation strategy identified with HD Wave Solution would have been different than standard | 5 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Comparison during the procedure | 4 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - About the Same | 13 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Presence of additional diagnostic signals | 0 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Much Better | 1 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Surface Area of Low Voltage | 8 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Location of Low Voltage | 8 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Much Worse | 0 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Better | 10 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Worse | 0 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Other | 0 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave Solution changed ablation strategy compared to standard configuration | 0 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Activation time/sequence | 3 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Differences Identified - Overall | 12 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Preferred Map - HD Wave Solution Configuration | 15 Maps |
| VT Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave Solution assisted in selection/identification of ablation strategy | 4 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave Solution changed ablation strategy compared to standard configuration | 0 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave Solution compared to standard configuration | 28 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Differences Identified - Overall | 16 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Location of Low Voltage | 5 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Surface Area of Low Voltage | 15 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Activation time/sequence | 0 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Fractionation | 1 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Presence of additional diagnostic signals | 0 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Other | 1 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Comparison during the procedure | 2 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave Solution assisted in selection/identification of ablation strategy | 2 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Comparison after the procedure | 26 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Ablation strategy identified with HD Wave Solution would have been different than standard | 8 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Much Better | 4 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Better | 8 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - About the Same | 16 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Worse | 0 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Much Worse | 0 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Preferred Map - HD Wave Solution Configuration | 22 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Preferred Map - Standard Configuration | 0 Maps |
| AFL Subjects | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Preferred Map - No Preference | 6 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Comparison during the procedure | 0 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Preferred Map - Standard Configuration | 1 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Worse | 0 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Other | 0 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Presence of additional diagnostic signals | 0 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Differences Identified - Overall | 5 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Much Worse | 0 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Fractionation | 0 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Activation time/sequence | 4 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave Solution compared to standard configuration | 10 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Preferred Map - HD Wave Solution Configuration | 1 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Surface Area of Low Voltage | 0 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Type of Differences - Location of Low Voltage | 1 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Better | 9 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - Much Better | 0 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Ablation strategy identified with HD Wave Solution would have been different than standard | 3 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Preferred Map - No Preference | 8 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | HD Wave solution vs. Standard - About the Same | 1 Maps |
| Other | Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. | Comparison after the procedure | 10 Maps |
Secondary
Substrate Characteristics Identified
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.
Time frame: During Procedure
Population: PersAF: Subjects indicated for ablation to treat PersAF for which substrate characteristic data was available, excluding subjects in which a device was used off-label.~VT: Subjects indicated for ablation to treat VT for which substrate characteristic data was available, excluding subjects in which a device was used off-label.~AFL: PersAF-indicated subjects also treated for AFL for which substrate characteristic data was available, excluding subjects in which a device was used off-label.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PersAF Subjects | Substrate Characteristics Identified | Low Voltage | 263 Participants |
| PersAF Subjects | Substrate Characteristics Identified | Fibrosis/Scar | 117 Participants |
| PersAF Subjects | Substrate Characteristics Identified | Focal Impulses | 8 Participants |
| PersAF Subjects | Substrate Characteristics Identified | Rotors | 4 Participants |
| PersAF Subjects | Substrate Characteristics Identified | Complex Fractionated Electrograms (CFE) | 52 Participants |
| PersAF Subjects | Substrate Characteristics Identified | Other | 48 Participants |
| VT Subjects | Substrate Characteristics Identified | Other | 4 Participants |
| VT Subjects | Substrate Characteristics Identified | Low Voltage | 19 Participants |
| VT Subjects | Substrate Characteristics Identified | Rotors | 0 Participants |
| VT Subjects | Substrate Characteristics Identified | Complex Fractionated Electrograms (CFE) | 2 Participants |
| VT Subjects | Substrate Characteristics Identified | Fibrosis/Scar | 17 Participants |
| VT Subjects | Substrate Characteristics Identified | Focal Impulses | 0 Participants |
| AFL Subjects | Substrate Characteristics Identified | Fibrosis/Scar | 34 Participants |
| AFL Subjects | Substrate Characteristics Identified | Focal Impulses | 4 Participants |
| AFL Subjects | Substrate Characteristics Identified | Other | 8 Participants |
| AFL Subjects | Substrate Characteristics Identified | Rotors | 1 Participants |
| AFL Subjects | Substrate Characteristics Identified | Low Voltage | 42 Participants |
| AFL Subjects | Substrate Characteristics Identified | Complex Fractionated Electrograms (CFE) | 9 Participants |
Other Pre-specified
Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects
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.
Time frame: Baseline, 6 months, and 12 months
Population: Available QOL data from enrolled subjects who provided written informed consent, confirmed to meet all inclusion criteria and none of the exclusion criteria, indicated for cardiac electroanatomical mapping and RF ablation procedure to treat sustained monomorphic ventricular tachycardia, and in which the HD Grid catheter was inserted and RF ablation procedure performed, excluding subjects in which a device was used off-label.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Depression Total Score: Baseline : Normal | 17 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Depression Total Score: Baseline : Borderline abnormal | 3 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Depression Total Score: Baseline : Abnormal | 0 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Depression Total Score: 6-Months : Normal | 11 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Depression Total Score: 6-Months : Borderline abnormal | 0 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Depression Total Score: 6-Months : Abnormal | 0 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Depression Total Score: 12-Months : Normal | 10 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Depression Total Score: 12-Months : Borderline abnormal | 2 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Depression Total Score: 12-Months : Abnormal | 0 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Anxiety Total Score: Baseline : Normal | 12 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Anxiety Total Score: Baseline : Borderline abnormal | 4 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Anxiety Total Score: Baseline : Abnormal | 4 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Anxiety Total Score: 6-Months : Normal | 9 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Anxiety Total Score: 6-Months : Borderline abnormal | 1 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Anxiety Total Score: 6-Months : Abnormal | 1 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Anxiety Total Score: 12-Months : Normal | 10 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Anxiety Total Score: 12-Months : Borderline abnormal | 0 Participants |
| PersAF Subjects | Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects | Anxiety Total Score: 12-Months : Abnormal | 2 Participants |
Other Pre-specified
Incidence of Periprocedural and Immediate Post Procedural (48hrs) Procedure- or Device- Related Adverse Events in All Subjects in Whom the HD Grid is Inserted.
Number of subjects in whom the HD Grid is inserted and experienced periprocedural and immediate post procedural (48hrs) procedure- or device- related adverse events.
Time frame: 48 hours
Population: Subjects who underwent ablation procedure and received electroanatomical mapping with Advisor HD Grid.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PersAF Subjects | Incidence of Periprocedural and Immediate Post Procedural (48hrs) Procedure- or Device- Related Adverse Events in All Subjects in Whom the HD Grid is Inserted. | Serious Adverse Events(<= 48 hrs) | 2 Participants |
| PersAF Subjects | Incidence of Periprocedural and Immediate Post Procedural (48hrs) Procedure- or Device- Related Adverse Events in All Subjects in Whom the HD Grid is Inserted. | Adverse Device Effects (<= 48 hrs) | 8 Participants |
| PersAF Subjects | Incidence of Periprocedural and Immediate Post Procedural (48hrs) Procedure- or Device- Related Adverse Events in All Subjects in Whom the HD Grid is Inserted. | Serious Adverse Device Effects (<= 48 hrs) | 12 Participants |
| VT Subjects | Incidence of Periprocedural and Immediate Post Procedural (48hrs) Procedure- or Device- Related Adverse Events in All Subjects in Whom the HD Grid is Inserted. | Adverse Device Effects (<= 48 hrs) | 0 Participants |
| VT Subjects | Incidence of Periprocedural and Immediate Post Procedural (48hrs) Procedure- or Device- Related Adverse Events in All Subjects in Whom the HD Grid is Inserted. | Serious Adverse Device Effects (<= 48 hrs) | 8 Participants |
| VT Subjects | Incidence of Periprocedural and Immediate Post Procedural (48hrs) Procedure- or Device- Related Adverse Events in All Subjects in Whom the HD Grid is Inserted. | Serious Adverse Events(<= 48 hrs) | 0 Participants |
Other Pre-specified
Long-term Success in VT Subjects at 12 Months
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.
Time frame: 12 months
Population: Subjects indicated for ablation to treat VT in which the HD grid catheter was inserted, and RF energy was applied according to label who completed their 12-month follow-up visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PersAF Subjects | Long-term Success in VT Subjects at 12 Months | Freedom from recurrence of sustained monomorphic VT and new or increased dose of class I/III AAD | 13 Participants |
| PersAF Subjects | Long-term Success in VT Subjects at 12 Months | Freedom from recurrence of sustained monomorphic VT on or off class I/III AAD | 13 Participants |
Other Pre-specified
Quality of Life: EQ-5D-5L Visual Analog Scale Scores and AFEQT Overall Scores in PersAF Subjects
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.
Time frame: Baseline, 6 months, 12 months
Population: Available QOL data from enrolled subjects who provided written informed consent, confirmed to meet all inclusion criteria and none of the exclusion criteria, indicated for cardiac electroanatomical mapping and RF ablation procedure to treat persistent atrial fibrillation, and in which the HD Grid catheter was inserted and RF ablation procedure performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PersAF Subjects | Quality of Life: EQ-5D-5L Visual Analog Scale Scores and AFEQT Overall Scores in PersAF Subjects | EQ-5D-5L Visual Analog Score : Baseline | 68.9 score on a scale | Standard Deviation 17.1 |
| PersAF Subjects | Quality of Life: EQ-5D-5L Visual Analog Scale Scores and AFEQT Overall Scores in PersAF Subjects | EQ-5D-5L Visual Analog Score : 6-Months | 77.8 score on a scale | Standard Deviation 17.1 |
| PersAF Subjects | Quality of Life: EQ-5D-5L Visual Analog Scale Scores and AFEQT Overall Scores in PersAF Subjects | EQ-5D-5L Visual Analog Score : 12-Months | 79.2 score on a scale | Standard Deviation 15.6 |
| PersAF Subjects | Quality of Life: EQ-5D-5L Visual Analog Scale Scores and AFEQT Overall Scores in PersAF Subjects | AFEQT Score: Baseline | 59.8 score on a scale | Standard Deviation 22.4 |
| PersAF Subjects | Quality of Life: EQ-5D-5L Visual Analog Scale Scores and AFEQT Overall Scores in PersAF Subjects | AFEQT Score: 6-Months | 85.6 score on a scale | Standard Deviation 16.8 |
| PersAF Subjects | Quality of Life: EQ-5D-5L Visual Analog Scale Scores and AFEQT Overall Scores in PersAF Subjects | AFEQT Score: 12-Months | 85.0 score on a scale | Standard Deviation 15.6 |
Other Pre-specified
Quality of Life: EQ-5D-5L Visual Analog Scale Scores in VT Subjects
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.
Time frame: Baseline, 6 months, 12 months
Population: Available QOL data from enrolled subjects who provided written informed consent, confirmed to meet all inclusion criteria and none of the exclusion criteria, indicated for cardiac electroanatomical mapping and RF ablation procedure to treat sustained monomorphic ventricular tachycardia, and in which the HD Grid catheter was inserted and RF ablation procedure performed, excluding subjects in which a device was used off-label.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PersAF Subjects | Quality of Life: EQ-5D-5L Visual Analog Scale Scores in VT Subjects | EQ-5D-5L Visual Analog Score: Baseline | 65.5 Score | Standard Deviation 23.1 |
| PersAF Subjects | Quality of Life: EQ-5D-5L Visual Analog Scale Scores in VT Subjects | EQ-5D-5L Visual Analog Score: 6-months | 75.2 Score | Standard Deviation 15.7 |
| PersAF Subjects | Quality of Life: EQ-5D-5L Visual Analog Scale Scores in VT Subjects | EQ-5D-5L Visual Analog Score: 12-Months | 66.4 Score | Standard Deviation 24.1 |
Other Pre-specified
Rate of Procedure- or Device-related Adverse Events and Cardiovascular Serious Adverse Events in All Subjects in Whom the HD Grid is Inserted .
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.
Time frame: 48 hours - 30 days
Population: Subjects who underwent ablation procedure and received electroanatomical mapping with Advisor HD Grid.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PersAF Subjects | Rate of Procedure- or Device-related Adverse Events and Cardiovascular Serious Adverse Events in All Subjects in Whom the HD Grid is Inserted . | Adverse Device Effects (48 hours - 30 days) | 2 Participants |
| PersAF Subjects | Rate of Procedure- or Device-related Adverse Events and Cardiovascular Serious Adverse Events in All Subjects in Whom the HD Grid is Inserted . | Serious Adverse Device Effects (48 hours - 30 days) | 6 Participants |
| PersAF Subjects | Rate of Procedure- or Device-related Adverse Events and Cardiovascular Serious Adverse Events in All Subjects in Whom the HD Grid is Inserted . | Serious Adverse Events (48 hours - 30 days) | 2 Participants |
| VT Subjects | Rate of Procedure- or Device-related Adverse Events and Cardiovascular Serious Adverse Events in All Subjects in Whom the HD Grid is Inserted . | Adverse Device Effects (48 hours - 30 days) | 0 Participants |
| VT Subjects | Rate of Procedure- or Device-related Adverse Events and Cardiovascular Serious Adverse Events in All Subjects in Whom the HD Grid is Inserted . | Serious Adverse Device Effects (48 hours - 30 days) | 1 Participants |
| VT Subjects | Rate of Procedure- or Device-related Adverse Events and Cardiovascular Serious Adverse Events in All Subjects in Whom the HD Grid is Inserted . | Serious Adverse Events (48 hours - 30 days) | 0 Participants |
Other Pre-specified
Rate of Subjects Free From Repeat Ablations After Study Procedure During 12-month Follow up
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.
Time frame: Through 12 months
Population: PersAF: Subjects indicated for ablation to treat PersAF who received RF energy delivery according to label and electroanatomical mapping with Advisor HD Grid for which 12-month follow-up data regarding repeat ablations was available.~VT: Subjects indicated for ablation to treat VT who received RF energy delivery according to label and electroanatomical mapping with Advisor HD Grid for which 6-month follow-up data regarding repeat ablations was available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PersAF Subjects | Rate of Subjects Free From Repeat Ablations After Study Procedure During 12-month Follow up | 291 Participants |
| VT Subjects | Rate of Subjects Free From Repeat Ablations After Study Procedure During 12-month Follow up | 13 Participants |