Trial Outcomes & Findings for Advisor HD Grid Observational Study (NCT NCT03733392)

Last Updated: 2024-04-16

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

379 participants

Primary outcome timeframe

Immediate post procedure

Results posted on

2024-04-16

Participant Flow

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 The remaining 7 subjects (5 PersAF, 2 VT) were withdrawn prior to procedure due to presence of thrombus, mapping system incompatible with the HD Grid, subject withdrawal of consent, and/or early enrollment closure.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	339	40
Overall Study Ablation Procedure	334	38
Overall Study Pre-Discharge	334	37
Overall Study 6-month Follow-Up	312	28
Overall Study 12-Month Follow-Up	299	26
Overall Study COMPLETED	299	26
Overall Study NOT COMPLETED	40	14

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	11	1
Overall Study Death	1	0
Overall Study Lost to Follow-up	5	0
Overall Study Protocol Violation	0	1
Overall Study Inclusion/Exclusion Criteria Not Met or Non-eligibility	4	4
Overall Study Incomplete Ablation or Ablation not done	0	5
Overall Study Patient Non-Compliance	2	1
Overall Study Subject did not complete follow-up but did not meet criteria for lost-to-follow-up	12	0
Overall Study Withdrawal prior to procedure	5	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PersAF Subjects n=334 Participants 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.	VT Subjects n=38 Participants 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.	Total n=372 Participants Total of all reporting groups
Age, Continuous	64.2 years STANDARD_DEVIATION 10.4 • n=334 Participants	64.0 years STANDARD_DEVIATION 13.4 • n=38 Participants	64.1 years STANDARD_DEVIATION 10.7 • n=372 Participants
Sex: Female, Male Female	80 Participants n=334 Participants	6 Participants n=38 Participants	86 Participants n=372 Participants
Sex: Female, Male Male	254 Participants n=334 Participants	32 Participants n=38 Participants	286 Participants n=372 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	24 participants n=334 Participants	1 participants n=38 Participants	25 participants n=372 Participants
Region of Enrollment Austria	73 participants n=334 Participants	2 participants n=38 Participants	75 participants n=372 Participants
Region of Enrollment Netherlands	15 participants n=334 Participants	0 participants n=38 Participants	15 participants n=372 Participants
Region of Enrollment Denmark	2 participants n=334 Participants	0 participants n=38 Participants	2 participants n=372 Participants
Region of Enrollment Italy	9 participants n=334 Participants	1 participants n=38 Participants	10 participants n=372 Participants
Region of Enrollment South Africa	36 participants n=334 Participants	11 participants n=38 Participants	47 participants n=372 Participants
Region of Enrollment France	59 participants n=334 Participants	4 participants n=38 Participants	63 participants n=372 Participants
Region of Enrollment Australia	36 participants n=334 Participants	7 participants n=38 Participants	43 participants n=372 Participants
Region of Enrollment Portugal	3 participants n=334 Participants	0 participants n=38 Participants	3 participants n=372 Participants
Region of Enrollment Germany	72 participants n=334 Participants	4 participants n=38 Participants	76 participants n=372 Participants
Region of Enrollment Spain	5 participants n=334 Participants	8 participants n=38 Participants	13 participants n=372 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PersAF Subjects n=334 Participants 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.	VT Subjects n=16 Participants 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.	AFL Subjects Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Rate of Subjects With Acute Success	287 Participants	14 Participants	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PersAF Subjects n=299 Participants 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.	VT Subjects n=15 Participants 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.	AFL Subjects Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Rate of Subjects With Long-term Success Freedom from arrhythmia recurrence and new or increased dose of class I/III AAD	168 Participants	14 Participants	—	—
Rate of Subjects With Long-term Success Freedom from arrhythmia recurrence on or off class I/III AAD	173 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	PersAF Subjects n=333 Participants 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.	VT Subjects n=20 Participants 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.	AFL Subjects n=51 Participants Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Overall Procedure Time	134.3 minutes Standard Deviation 51.3	174.1 minutes Standard Deviation 54.2	171.4 minutes Standard Deviation 60.3	—

SECONDARY outcome

Timeframe: 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:

Defined as duration of time RF energy is delivered

Outcome measures

Outcome measures
Measure	PersAF Subjects n=319 Participants 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.	VT Subjects n=17 Participants 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.	AFL Subjects n=48 Participants Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Radiofrequency (RF) Time	32.0 minutes Standard Deviation 23.2	35.1 minutes Standard Deviation 30.5	37.6 minutes Standard Deviation 36.8	—

SECONDARY outcome

Timeframe: 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.

Defined as total time subject is exposed to fluoroscopy

Outcome measures

Outcome measures
Measure	PersAF Subjects n=326 Participants 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.	VT Subjects n=20 Participants 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.	AFL Subjects n=50 Participants Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Fluoroscopy Time	14.5 minutes Standard Deviation 11.3	31.3 minutes Standard Deviation 17.4	13.7 minutes Standard Deviation 10.6	—

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	PersAF Subjects n=411 Maps 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.	VT Subjects n=52 Maps 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.	AFL Subjects n=38 Maps Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other n=31 Maps Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Mapping Time Associated With Mapping Arrhythmia	12.8 minutes Standard Deviation 8.8	13.6 minutes Standard Deviation 11.8	20.6 minutes Standard Deviation 15.3	7.3 minutes Standard Deviation 5.6

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	PersAF Subjects n=411 Maps 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.	VT Subjects n=52 Maps 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.	AFL Subjects n=38 Maps Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other n=31 Maps Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Number of Mapping Points Collected	10150.8 Mapping points collected Standard Deviation 8390.4	10533.1 Mapping points collected Standard Deviation 11282.8	16496.2 Mapping points collected Standard Deviation 17207.5	3902.5 Mapping points collected Standard Deviation 4125.0

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	PersAF Subjects n=411 Maps 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.	VT Subjects n=52 Maps 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.	AFL Subjects n=38 Maps Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other n=31 Maps Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Number of Used Mapping Points Per Minute	203.2 Used Mapping Points/Minute Standard Deviation 172.0	170.8 Used Mapping Points/Minute Standard Deviation 157.5	81.9 Used Mapping Points/Minute Standard Deviation 50.7	180.1 Used Mapping Points/Minute Standard Deviation 199.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PersAF Subjects n=334 Participants 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.	VT Subjects n=20 Participants 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.	AFL Subjects n=51 Participants Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Substrate Characteristics Identified Low Voltage	263 Participants	19 Participants	42 Participants	—
Substrate Characteristics Identified Fibrosis/Scar	117 Participants	17 Participants	34 Participants	—
Substrate Characteristics Identified Focal Impulses	8 Participants	0 Participants	4 Participants	—
Substrate Characteristics Identified Rotors	4 Participants	0 Participants	1 Participants	—
Substrate Characteristics Identified Complex Fractionated Electrograms (CFE)	52 Participants	2 Participants	9 Participants	—
Substrate Characteristics Identified Other	48 Participants	4 Participants	8 Participants	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	PersAF Subjects n=413 Maps 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.	VT Subjects n=334 Participants 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.	AFL Subjects n=38 Maps Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other n=31 Maps Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Map Type Used to Define Ablation Strategy Peak-to-Peak	322 Maps	9 Maps	24 Maps	12 Maps
Map Type Used to Define Ablation Strategy Local Activation Time (LAT)	47 Maps	42 Maps	13 Maps	19 Maps
Map Type Used to Define Ablation Strategy CFE Mean	32 Maps	0 Maps	1 Maps	0 Maps
Map Type Used to Define Ablation Strategy Fractionation	9 Maps	1 Maps	0 Maps	0 Maps
Map Type Used to Define Ablation Strategy Peak-Negative	3 Maps	0 Maps	0 Maps	0 Maps

SECONDARY outcome

Timeframe: During Procedure

Population: Analyzed maps with original electrode configuration as HD Wave Solution and comparable retrospective map generated in standard configuration

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

Outcome measures

Outcome measures
Measure	PersAF Subjects n=213 Maps 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.	VT Subjects n=25 Maps 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.	AFL Subjects n=28 Maps Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other n=13 Maps Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. HD Wave Solution compared to standard configuration	187 Maps	24 Maps	28 Maps	10 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. Differences Identified - Overall	117 Maps	12 Maps	16 Maps	5 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. Type of Differences - Location of Low Voltage	69 Maps	8 Maps	5 Maps	1 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. Type of Differences - Surface Area of Low Voltage	70 Maps	8 Maps	15 Maps	0 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. Type of Differences - Activation time/sequence	4 Maps	3 Maps	0 Maps	4 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. Type of Differences - Fractionation	33 Maps	1 Maps	1 Maps	0 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. Type of Differences - Presence of additional diagnostic signals	1 Maps	0 Maps	0 Maps	0 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. Type of Differences - Other	3 Maps	0 Maps	1 Maps	0 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. Comparison during the procedure	31 Maps	4 Maps	2 Maps	0 Maps
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	4 Maps	2 Maps	—
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	0 Maps	0 Maps	—
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. Comparison after the procedure	156 Maps	20 Maps	26 Maps	10 Maps
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	5 Maps	8 Maps	3 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. HD Wave solution vs. Standard - Much Better	26 Maps	1 Maps	4 Maps	0 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. HD Wave solution vs. Standard - Better	96 Maps	10 Maps	8 Maps	9 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. HD Wave solution vs. Standard - About the Same	61 Maps	13 Maps	16 Maps	1 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. HD Wave solution vs. Standard - Worse	4 Maps	0 Maps	0 Maps	0 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. HD Wave solution vs. Standard - Much Worse	0 Maps	0 Maps	0 Maps	0 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. Preferred Map - HD Wave Solution Configuration	150 Maps	15 Maps	22 Maps	1 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. Preferred Map - Standard Configuration	7 Maps	1 Maps	0 Maps	1 Maps
Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision. Preferred Map - No Preference	30 Maps	8 Maps	6 Maps	8 Maps

SECONDARY outcome

Timeframe: 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..

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.

Outcome measures

Outcome measures
Measure	PersAF Subjects n=334 Participants 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.	VT Subjects n=20 Participants 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.	AFL Subjects Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Maneuverability of HD Grid Catheter Sufficient contact occasionally (11-50%)	0 Participants	0 Participants	—	—
Maneuverability of HD Grid Catheter Difficulty reaching Left Atrium	66 Participants	0 Participants	—	—
Maneuverability of HD Grid Catheter Difficulty reaching Right Atrium	4 Participants	0 Participants	—	—
Maneuverability of HD Grid Catheter Difficulty reaching Left Ventricle	0 Participants	7 Participants	—	—
Maneuverability of HD Grid Catheter Difficulty reaching Right Ventricle	1 Participants	1 Participants	—	—
Maneuverability of HD Grid Catheter Attempted to maneuver HD Grid into the Pulmonary veins	327 Participants	2 Participants	—	—
Maneuverability of HD Grid Catheter Successful maneuvering into the Pulmonary veins	325 Participants	2 Participants	—	—
Maneuverability of HD Grid Catheter Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - None	166 Participants	2 Participants	—	—
Maneuverability of HD Grid Catheter Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - Minimal	164 Participants	14 Participants	—	—
Maneuverability of HD Grid Catheter Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - Half the time	1 Participants	3 Participants	—	—
Maneuverability of HD Grid Catheter Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - Most of the time	2 Participants	0 Participants	—	—
Maneuverability of HD Grid Catheter Frequency of ectopic beats/other arrhythmias due to HD Grid Catheter - Contact tachycardia	1 Participants	1 Participants	—	—
Maneuverability of HD Grid Catheter Attempted to make contact with cardiac wall	333 Participants	20 Participants	—	—
Maneuverability of HD Grid Catheter Sufficient contact all of the time (100%)	67 Participants	0 Participants	—	—
Maneuverability of HD Grid Catheter Sufficient contact most of the time (91-99%)	233 Participants	5 Participants	—	—
Maneuverability of HD Grid Catheter Sufficient contact some of the time (52-90%)	33 Participants	15 Participants	—	—
Maneuverability of HD Grid Catheter Sufficient contact rarely (0-10%)	0 Participants	0 Participants	—	—
Maneuverability of HD Grid Catheter Difficult reaching a specific area of the heart with HD Grid	70 Participants	7 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PersAF Subjects n=334 Participants 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.	VT Subjects n=20 Participants 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.	AFL Subjects Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms Electrogram signals assessed for quality/noise compared to ablation catheter	255 Participants	15 Participants	—	—
HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms HD Grid identified signals of interest not identified with ablation catheter	205 Participants	14 Participants	—	—
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	6 Participants	—	—
HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms HD Grid electrogram quality/noise vs. ablation catheters at same cardiac location - Better	130 Participants	9 Participants	—	—
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	0 Participants	—	—
HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms HD Grid electrogram quality/noise vs. ablation catheters at same cardiac location - Worse	0 Participants	0 Participants	—	—
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	0 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	PersAF Subjects n=334 Participants 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.	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.	AFL Subjects Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Ablation Strategy(s) Used for PersAF Subjects PVI (RSPV)	174 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects PVI (RIPV)	168 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects PVI (Common Right)	132 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects PVI (LSPV)	145 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects PVI (LIPV)	143 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects PVI (Common Left)	147 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Roof	66 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Posterior Wall Isolation	41 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Cavo tricuspid isthmuc	38 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Mitral Isthmus	36 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Complex Fractionated Electrograms (CFE)	25 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Box Isolation of Fibrotic Area	16 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Left Atrial Appendage (LAA) Focal Ablation	9 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Coronary Sinus	9 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Superior Vena Cava Isolation	8 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Other	6 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Crista Terminalis	5 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Eustachian Ridge	2 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects LAA Isolation	1 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Fossa Ovalis	1 Participants	—	—	—
Ablation Strategy(s) Used for PersAF Subjects Ligament of Marshall	1 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	PersAF Subjects n=20 Participants 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.	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.	AFL Subjects Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Ablation Strategy(s) Used for VT Subjects Late Potential in Scar	15 Participants	—	—	—
Ablation Strategy(s) Used for VT Subjects Low Voltage in Scar	9 Participants	—	—	—
Ablation Strategy(s) Used for VT Subjects Regions of Pace-match	9 Participants	—	—	—
Ablation Strategy(s) Used for VT Subjects Dechanneling exit site	7 Participants	—	—	—
Ablation Strategy(s) Used for VT Subjects Fibrotic Areas	2 Participants	—	—	—
Ablation Strategy(s) Used for VT Subjects Scar Homogenization	0 Participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 hours

Population: Subjects who underwent ablation procedure and received electroanatomical mapping with Advisor HD Grid.

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

Outcome measures

Outcome measures
Measure	PersAF Subjects n=334 Participants 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.	VT Subjects n=38 Participants 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.	AFL Subjects Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not 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	0 Participants	—	—
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	8 Participants	—	—
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	0 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 hours - 30 days

Population: Subjects who underwent ablation procedure and received electroanatomical mapping with Advisor HD Grid.

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.

Outcome measures

Outcome measures
Measure	PersAF Subjects n=334 Participants 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.	VT Subjects n=38 Participants 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.	AFL Subjects Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not 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	0 Participants	—	—
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	0 Participants	—	—
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	1 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PersAF Subjects n=300 Participants 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.	VT Subjects n=14 Participants 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.	AFL Subjects Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not subjects
Rate of Subjects Free From Repeat Ablations After Study Procedure During 12-month Follow up	291 Participants	13 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PersAF Subjects n=334 Participants 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.	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.	AFL Subjects Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not 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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PersAF Subjects n=20 Participants 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.	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.	AFL Subjects Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not 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	—	—	—
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	—	—	—
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PersAF Subjects n=20 Participants 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.	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.	AFL Subjects Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not 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	—	—	—
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	—	—	—
Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects Depression Total Score: Baseline : Abnormal	0 Participants	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects Anxiety Total Score: Baseline : Normal	12 Participants	—	—	—
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	—	—	—
Count of Participants With Normal, Borderline Abnormal, and Abnormal Anxiety and Depression HADS Scores in VT Subjects Anxiety Total Score: Baseline : Abnormal	4 Participants	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PersAF Subjects n=16 Participants 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.	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.	AFL Subjects Atrial Flutter (AFL) subjects includes all subjects for which the site responded 'Yes' to the question 'Was the subject in atypical Atrial Flutter during the procedure?' on the Procedure General Case Report Form (CRF). All AFL subjects had a primary indication of PersAF or VT and thus are also included in one of the first two columns.	Other Arrhythmias other than Persistent AF, AFL, or VT maps were generated with the intent to treat. Counts will be in maps not 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	—	—	—
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	—	—	—

Adverse Events

PersAF Subjects

Serious events: 39 serious events

Other events: 10 other events

Deaths: 1 deaths

VT Subjects

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	PersAF Subjects n=334 participants at risk 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.	VT Subjects n=38 participants at risk 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.
Vascular disorders ARTERIOVENOUS FISTULA	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders HYPOTENSION	0.60% 2/334 • Number of events 2 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Eye disorders BLURRED VISION	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Nervous system disorders SHORT TERM LAPSES IN MEMORY	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders PAIN (NON-CARDIAC)	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders PERICARDIAL EFFUSION	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Skin and subcutaneous tissue disorders SKIN BURNS/DERMATITIS/ERYTHEMA	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders VASCULAR ACCESS COMPLICATIONS	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders PAIN (NON-CARDIAC)	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.

Additional Information

Emily Jesser, Ph.D.

Abbott

Phone: 763-954-1350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	PersAF Subjects n=334 participants at risk 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.	VT Subjects n=38 participants at risk 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.
Cardiac disorders ARRHYTHMIA NEW	3.0% 10/334 • Number of events 10 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	2.6% 1/38 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders ARRHYTHMIA PRE-EXISTING	1.2% 4/334 • Number of events 4 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	2.6% 1/38 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Infections and infestations INFECTION	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	2.6% 1/38 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders PERICARDIAL EFFUSION	0.00% 0/334 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	5.3% 2/38 • Number of events 2 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/334 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	2.6% 1/38 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders RESPIRATORY COMPROMISE/DECOMPENSATION	0.00% 0/334 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	2.6% 1/38 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Blood and lymphatic system disorders THROMBOSIS/THROMBUS	0.00% 0/334 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	2.6% 1/38 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders TRANSIENT ISCHEMIC ATTACK (TIA)	0.00% 0/334 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	5.3% 2/38 • Number of events 2 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Injury, poisoning and procedural complications BLEEDING/ANEMIA	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders CARDIAC ARREST	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Nervous system disorders CEREBROVASCULAR ACCIDENT/ STROKE	0.60% 2/334 • Number of events 2 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders CHEST PAIN/ANGINA (CARDIAC)	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders CORONARY ARTERY THROMBOSIS/OCCLUSION	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders EMBOLIC EVENT	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders HEART FAILURE	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders HYPERTENSION	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders INCOMPLETE AV, SINUS NODE, OR OTHER HEART BLOCK	0.60% 2/334 • Number of events 2 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	2.6% 1/38 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders MYOCARDIAL INFARCTION	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders PAIN (NON-CARDIAC)	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders PALPITATION	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders PNEUMONIA	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders PULMONARY EDEMA	0.60% 2/334 • Number of events 2 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders PULMONARY VEIN STENOSIS	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders VASCULAR ACCESS COMPLICATIONS	0.90% 3/334 • Number of events 3 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders VASCULAR BLEEDING/LOCAL HEMATOMAS/ECCHYMOSIS	0.90% 3/334 • Number of events 3 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Musculoskeletal and connective tissue disorders ARM WEAKNESS	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders PREAUTOMATIC PAUSE	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders CHRONOTROPIC INCOMPETENCE	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	0.00% 0/38 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders CARDIAC PERFORATION OR TAMPONADE	0.30% 1/334 • Number of events 1 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.	10.5% 4/38 • Number of events 4 • 12 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.