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.
Study Type
OBSERVATIONAL
Enrollment
379
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.
The Alfred Hospital
Melbourne, New South Wales, Australia
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
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)
Overall Procedure Time
Overall procedure time is defined as time from initial catheter insertion to final catheter removal.
Time frame: During procedure
Radiofrequency (RF) Time
Defined as duration of time RF energy is delivered
Time frame: During Procedure
Fluoroscopy Time
Defined as total time subject is exposed to fluoroscopy
Time frame: During Procedure
Mapping Time Associated With Mapping Arrhythmia
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The Prince Charles Hospital
Chermside, Qslnd, Australia
Flinders Private Hospital
Bedford Park, South Australia, Australia
Monash Medical Centre
Clayton, Victori, Australia
KH Wiener Neustadt
Wiener Neustadt, L Austr, Austria
A. ö. Krankenhaus der Elisabethinen Linz
Linz, Upper Austria, Austria
St. Paul's Hospital
Vancouver, British Columbia, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Institut de Cardiologie de Quebec (Hôpital Laval)
Québec, Quebec, Canada
Skejby University Hospital
Aarhus, Denmark
...and 15 more locations
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
Number of Mapping Points Collected
Defined as total number of mapping points collected for the creation of each map.
Time frame: During Procedure
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
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
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
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
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
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
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
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