Cardiac Arrhythmias
Conditions
Brief summary
The objective of this registry is to assess and characterize the use and performance of the EnSite Precision™ Cardiac Mapping System and the EnSite Precision™ Software V2.0 in a variety of electrophysiological (EP) procedures and clinical settings. This registry will assess the clinical performance of the system in a controlled, real-world environment after commercial release. Up to 500 subjects will be enrolled in up to 50 sites worldwide. Data will be collected at enrollment/baseline, procedure and pre-discharge. There is no long-term follow-up required for this registry. The anticipated registry enrollment is about 6-7 months.
Detailed description
The use of the EnSite Precision™ Cardiac Mapping System will be assessed by collecting feedback from physicians/operators through specific questions. The performance of the EnSite Precision™ Cardiac Mapping System will be assessed by collecting procedure data and adverse events. A detailed Data Management Plan will be established to ensure consistency of the data. This document will include procedures used for data review, database cleaning, and issuing and resolving data queries. If appropriate, the Data Management Plan may be updated throughout the registry duration. All revisions will be tracked and document controlled. Case Report Form data will be captured in a validated electronic database management system hosted by St. Jude Medical. Centralized monitoring will occur through routine internal data review. This monitoring is designed to identify missing and inconsistent data, data outliers, and potential protocol deviations that may be indicative of site non-compliance. On-site monitoring may occur at the discretion of the sponsor.
Interventions
PROCEDURECardiac Ablation
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients indicated for a cardiac EP study and ablation procedure using a 3D mapping system * Over 18 years of age * Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations
Exclusion criteria
* Contraindication to anticoagulation * Presence of thrombus * Implanted with mechanical prosthetic heart valve * Recent (\<3 months) myocardial Infarction or unstable angina or coronary artery by-pass * Pregnant or nursing * Individuals whose willingness to volunteer in a registry, in the judgment of investigator or public authorities, could be unduly influenced by lack of or loss of the autonomy due to immaturity, or mental disability, or adverse personal circumstances, or hierarchical influence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts | during procedure | summarizing the count and percentage of patients with unrecoverable shifts |
| Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | during procedure | mapping points collected and used will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) |
| Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability | during procedure | summarizing the count and percentage of patients with overall system stability |
| Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy | during procedure | summarizing the count and percentage of patients with accurate geometry |
| Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | during procedure | mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: Manual AutoMap™ TurboMap™ |
| Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping | during procedure | mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: Manual |
| Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping | during procedure | mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: AutoMap module |
| Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping | during procedure | mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: TurboMap module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement | during procedure | Count and percentage of subjects where the AutoMark feature assisted in identifying gaps in lesion lines |
| EnSite Precision™ Cardiac Mapping System Assessment | during procedure | Count and percentage of subjects in whom the mapping system was reported to be excellent, very good, good, poor and N/A |
Countries
Italy
Participant flow
Recruitment details
Any patient indicated to undergo a cardiac electrophysiology (EP) mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System was considered eligible.
Participants by arm
| Arm | Count |
|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping Any patient indicated to undergo a cardiac EP mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System was considered eligible. Subjects meeting all inclusion criteria and not meeting any exclusion criteria were enrolled in the study. | 503 |
| Total | 503 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inclusion/Exclusion criteria not met | 3 |
| Overall Study | No informed consent | 1 |
| Overall Study | No procedure performed | 2 |
| Overall Study | Physician Decision | 6 |
Baseline characteristics
| Characteristic | Subjects With EnSite Precision™ Cardiac Mapping | — |
|---|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 13.2 | — |
| Ejection Fraction Abnormal per physician/standard of care | 285 Participants | — |
| Ejection Fraction Normal per physician/standard of care | 96 Participants | — |
| Ejection Fraction Not Available | 1 Participants | — |
| Ejection Fraction Not Evaluated | 121 Participants | — |
| Ejection Fraction | 54.2 % STANDARD_DEVIATION 12 | — |
| Indication for Procedure Atrial Fibrillation | 277 Participants | — |
| Indication for Procedure Atrial Flutter | 67 Participants | — |
| Indication for Procedure Other | 46 Participants | — |
| Indication for Procedure Supraventricular Tachycardia | 96 Participants | — |
| Indication for Procedure Ventricular Tachycardia | 56 Participants | — |
| Left Atrial Diameter | 43.1 mm STANDARD_DEVIATION 8.3 | — |
| Left Atrial Volume | 82.3 ml STANDARD_DEVIATION 42.7 | — |
| NYHA Heart Failure Classification Class I | 108 Participants | — |
| NYHA Heart Failure Classification Class II | 59 Participants | — |
| NYHA Heart Failure Classification Class III | 16 Participants | — |
| NYHA Heart Failure Classification Class IV | 1 Participants | — |
| NYHA Heart Failure Classification Not Available | 2 Participants | — |
| NYHA Heart Failure Classification Not Evaluated | 317 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 23 Participants | — |
| Region of Enrollment Belgium | 2 Participants | — |
| Region of Enrollment Finland | 13 Participants | — |
| Region of Enrollment France | 159 Participants | — |
| Region of Enrollment Germany | 63 Participants | — |
| Region of Enrollment Italy | 172 Participants | — |
| Region of Enrollment Netherlands | 69 Participants | — |
| Region of Enrollment United Kingdom | 2 Participants | — |
| Sex: Female, Male Female | 179 Participants | — |
| Sex: Female, Male Male | 324 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 503 |
| other Total, other adverse events | 2 / 503 |
| serious Total, serious adverse events | 10 / 503 |
Outcome results
Primary
Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy
summarizing the count and percentage of patients with accurate geometry
Time frame: during procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping | Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy | Geometry found was anatomically accurate | 461 Participants |
| Subjects With EnSite Precision™ Cardiac Mapping | Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy | Geometry found was not anatomically accurate | 34 Participants |
| Subjects With EnSite Precision™ Cardiac Mapping | Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy | Geometry anatomical accuracy not available | 8 Participants |
Primary
Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability
summarizing the count and percentage of patients with overall system stability
Time frame: during procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping | Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability | System was stable throughout the procedure | 455 Participants |
| Subjects With EnSite Precision™ Cardiac Mapping | Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability | System was not stable throughout the procedure | 46 Participants |
| Subjects With EnSite Precision™ Cardiac Mapping | Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability | Stability throughout the procedure not available | 2 Participants |
Primary
Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts
summarizing the count and percentage of patients with unrecoverable shifts
Time frame: during procedure
Population: 46 procedures with system not stable throughout the procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping | Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts | Map could be recovered | 36 Participants |
| Subjects With EnSite Precision™ Cardiac Mapping | Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts | Map could not be recovered | 10 Participants |
Primary
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: Manual AutoMap™ TurboMap™
Time frame: during procedure
Population: 603 total maps were created in 421 subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Manual Map | 14.2 min | Standard Deviation 13.9 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | AutoMap | 13.1 min | Standard Deviation 11.9 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | TurboMap | 6.6 min | Standard Deviation 5.7 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Other | 4.0 min | Standard Deviation 1.4 |
Primary
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: AutoMap module
Time frame: during procedure
Population: 526 total AutoMap Module maps were created.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping | Atrial Fibrillation | 11.3 min | Standard Deviation 5.4 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping | Atrial Flutter | 10.1 min | Standard Deviation 7.3 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping | Sinus Rhythm | 14.3 min | Standard Deviation 13.5 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping | Atrial Tachycardia | 8.4 min | Standard Deviation 5.8 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping | Atrioventricular Reentry Tachycardia | 6.0 min | — |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping | Atrioventricular Nodal Reentry Tachycardia | 11.0 min | Standard Deviation 1.4 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping | Ventricular Tachycardia | 16.3 min | Standard Deviation 16.2 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping | Other | 14.3 min | Standard Deviation 10.8 |
Primary
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: Manual
Time frame: during procedure
Population: 62 total Manual maps were created.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping | Sinus Rhythm | 11.5 min | Standard Deviation 9.8 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping | Atrial Fibrillation | 20.0 min | — |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping | Atrial Flutter | 8.8 min | Standard Deviation 4.3 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping | Atrial Tachycardia | 18.3 min | Standard Deviation 18.2 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping | Atrioventricular Reentry Tachycardia | 10.0 min | Standard Deviation 0 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping | Atrioventricular Nodal Reentry Tachycardia | 3.6 min | Standard Deviation 3.3 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping | Ventricular Tachycardia | 23.4 min | Standard Deviation 19.3 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping | Other | 14.6 min | Standard Deviation 11.6 |
Primary
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: TurboMap module
Time frame: during procedure
Population: 13 total TurboMap Module maps were created.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping | Sinus Rhythm | 4.3 min | Standard Deviation 1.2 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping | Atrial Fibrillation | 17.0 min | — |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping | Atrial Flutter | 3.3 min | Standard Deviation 0.5 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping | Atrial Tachycardia | 8.0 min | Standard Deviation 9.9 |
| Subjects With EnSite Precision™ Cardiac Mapping | Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping | Other | 9.0 min | Standard Deviation 7.2 |
Primary
Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters
mapping points collected and used will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate)
Time frame: during procedure
Population: 606 total maps with mapping points used available were created in 421 subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | All Arrhythmias | 781.9 mapping points used | Standard Deviation 1062.1 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Sinus Rhythm | 954.5 mapping points used | Standard Deviation 1245.6 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Atrial Fibrillation | 1127.3 mapping points used | Standard Deviation 801.6 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Atrial Flutter | 828.8 mapping points used | Standard Deviation 983.4 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Atrial Tachycardia | 612.3 mapping points used | Standard Deviation 663.6 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Atrioventricular Reentry Tachycardia | 85.5 mapping points used | Standard Deviation 103.9 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Arioventricular Nodal Reentry Tachycardia | 56.7 mapping points used | Standard Deviation 134.2 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Ventricular Tachycardia | 318.1 mapping points used | Standard Deviation 623.7 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Other | 104.3 mapping points used | Standard Deviation 182.6 |
Primary
Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters
mapping points collected and used will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate)
Time frame: during procedure
Population: 606 total maps with mapping points collected available were created in 421 subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | All Arrhythmias | 2074.7 mapping points collected | Standard Deviation 3377.2 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Sinus Rhythm | 2396.0 mapping points collected | Standard Deviation 3638.5 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Atrial Fibrillation | 3124.3 mapping points collected | Standard Deviation 3253.4 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Atrial Flutter | 2484.3 mapping points collected | Standard Deviation 4440.9 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Atrial Tachycardia | 1957.0 mapping points collected | Standard Deviation 2331 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Atrioventricular Reentry Tachycardia | 143.5 mapping points collected | Standard Deviation 169 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Arioventricular Nodal Reentry Tachycardia | 95.0 mapping points collected | Standard Deviation 237.6 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Ventricular Tachycardia | 841.9 mapping points collected | Standard Deviation 1698.7 |
| Subjects With EnSite Precision™ Cardiac Mapping | Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters | Other | 208.4 mapping points collected | Standard Deviation 438 |
Secondary
Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement
Count and percentage of subjects where the AutoMark feature assisted in identifying gaps in lesion lines
Time frame: during procedure
Population: 117 subjects had gaps identified in the lesion line
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping | Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement | AutoMark assisted in identifying gaps | 34 Participants |
| Subjects With EnSite Precision™ Cardiac Mapping | Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement | AutoMark did not assist in identifying gaps | 83 Participants |
Secondary
Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement
Count and percentage of subjects where the AutoMark feature was easy to use
Time frame: during procedure
Population: 373 procedures used AutoMark
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping | Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement | AutoMark Feature ease of use not available | 17 Participants |
| Subjects With EnSite Precision™ Cardiac Mapping | Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement | AutoMark feature was easy to use | 352 Participants |
| Subjects With EnSite Precision™ Cardiac Mapping | Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement | AutoMark feature was not easy to use | 4 Participants |
Secondary
EnSite Precision™ Cardiac Mapping System Assessment
Count and percentage of subjects in whom the mapping system was reported to be excellent, very good, good, poor and N/A
Time frame: during procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping | EnSite Precision™ Cardiac Mapping System Assessment | Excellent | 153 Participants |
| Subjects With EnSite Precision™ Cardiac Mapping | EnSite Precision™ Cardiac Mapping System Assessment | Very Good | 202 Participants |
| Subjects With EnSite Precision™ Cardiac Mapping | EnSite Precision™ Cardiac Mapping System Assessment | Good | 139 Participants |
| Subjects With EnSite Precision™ Cardiac Mapping | EnSite Precision™ Cardiac Mapping System Assessment | Poor | 8 Participants |
| Subjects With EnSite Precision™ Cardiac Mapping | EnSite Precision™ Cardiac Mapping System Assessment | Not Applicable | 1 Participants |
Secondary
EnSite Precision™ Cardiac Mapping System Assessment
Overall procedure time summarized using mean and standard deviation
Time frame: during procedure
Population: 501 subjects had procedure time available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects With EnSite Precision™ Cardiac Mapping | EnSite Precision™ Cardiac Mapping System Assessment | 116.8 mins | Standard Deviation 52.2 |