Trial Outcomes & Findings for EnSite Precision™ 2.0 Registry (NCT NCT02757430)

NCT ID: NCT02757430

Last Updated: 2019-05-06

Results Overview

summarizing the count and percentage of patients with accurate geometry

• Recruitment status: COMPLETED
• Target enrollment: 515 participants
• Primary outcome timeframe: during procedure
• Results posted on: 2019-05-06

Participant Flow

Any patient indicated to undergo a cardiac electrophysiology (EP) mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System was considered eligible.

Participant milestones

Measure	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.
Overall Study STARTED	515
Overall Study Baseline Visits	503
Overall Study EP Mapping/Ablation Procedure	503
Overall Study COMPLETED	503
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	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.
Overall Study Physician Decision	6
Overall Study Inclusion/Exclusion criteria not met	3
Overall Study No informed consent	1
Overall Study No procedure performed	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=503 Participants 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.
Age, Continuous	59.6 years STANDARD_DEVIATION 13.2 • n=503 Participants
Sex: Female, Male Female	179 Participants n=503 Participants
Sex: Female, Male Male	324 Participants n=503 Participants
Region of Enrollment Italy	172 Participants n=503 Participants
Region of Enrollment Austria	23 Participants n=503 Participants
Region of Enrollment Belgium	2 Participants n=503 Participants
Region of Enrollment Finland	13 Participants n=503 Participants
Region of Enrollment France	159 Participants n=503 Participants
Region of Enrollment Germany	63 Participants n=503 Participants
Region of Enrollment Netherlands	69 Participants n=503 Participants
Region of Enrollment United Kingdom	2 Participants n=503 Participants
Ejection Fraction Abnormal per physician/standard of care	285 Participants n=503 Participants
Ejection Fraction Normal per physician/standard of care	96 Participants n=503 Participants
Ejection Fraction Not Evaluated	121 Participants n=503 Participants
Ejection Fraction Not Available	1 Participants n=503 Participants
Ejection Fraction	54.2 % STANDARD_DEVIATION 12.0 • n=285 Participants • Ejection Fraction provided when evaluated and considered by physician to be abnormal.
NYHA Heart Failure Classification Class I	108 Participants n=503 Participants
NYHA Heart Failure Classification Class II	59 Participants n=503 Participants
NYHA Heart Failure Classification Class III	16 Participants n=503 Participants
NYHA Heart Failure Classification Class IV	1 Participants n=503 Participants
NYHA Heart Failure Classification Not Evaluated	317 Participants n=503 Participants
NYHA Heart Failure Classification Not Available	2 Participants n=503 Participants
Left Atrial Diameter	43.1 mm STANDARD_DEVIATION 8.3 • n=113 Participants • Left Atrial Diameter provided when evaluated and considered by physician to be abnormal
Left Atrial Volume	82.3 ml STANDARD_DEVIATION 42.7 • n=136 Participants • Left Atrial Volume provided when evaluated and considered by physician to be abnormal
Indication for Procedure Atrial Fibrillation	277 Participants n=503 Participants
Indication for Procedure Atrial Flutter	67 Participants n=503 Participants
Indication for Procedure Supraventricular Tachycardia	96 Participants n=503 Participants
Indication for Procedure Ventricular Tachycardia	56 Participants n=503 Participants
Indication for Procedure Other	46 Participants n=503 Participants

PRIMARY outcome

Timeframe: during procedure

summarizing the count and percentage of patients with accurate geometry

Outcome measures

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=503 Participants 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.
Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy Geometry found was anatomically accurate	461 Participants
Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy Geometry found was not anatomically accurate	34 Participants
Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy Geometry anatomical accuracy not available	8 Participants

PRIMARY outcome

Timeframe: during procedure

Population: 603 total maps were created in 421 subjects.

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™

Outcome measures

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=603 maps 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.
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
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
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
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 outcome

Timeframe: during procedure

Population: 62 total Manual maps were created.

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

Outcome measures

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=62 manual maps 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.
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
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 Standard Deviation NA No standard deviation for N of 1
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
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
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 0.0
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
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
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 outcome

Timeframe: during procedure

Population: 526 total AutoMap Module maps were created.

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

Outcome measures

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=526 AutoMap Module Maps 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.
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
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
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
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
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 Standard Deviation NA No standard deviation for N of 1
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
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
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 outcome

Timeframe: during procedure

Population: 13 total TurboMap Module maps were created.

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

Outcome measures

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=13 TurboMap Module Maps 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.
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
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 Standard Deviation NA no standard deviation for N of 1
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
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
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 outcome

Timeframe: during procedure

Population: 606 total maps with mapping points collected available were created in 421 subjects.

mapping points collected and used will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate)

Outcome measures

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=606 maps 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.
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
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
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
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
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 2331.0
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 169.0
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
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
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 438.0

PRIMARY outcome

Timeframe: during procedure

Population: 606 total maps with mapping points used available were created in 421 subjects.

mapping points collected and used will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate)

Outcome measures

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=606 maps 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.
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
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
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
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
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
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
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
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
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 outcome

Timeframe: during procedure

summarizing the count and percentage of patients with overall system stability

Outcome measures

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=503 Participants 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.
Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability System was stable throughout the procedure	455 Participants
Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability System was not stable throughout the procedure	46 Participants
Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability Stability throughout the procedure not available	2 Participants

PRIMARY outcome

Timeframe: during procedure

Population: 46 procedures with system not stable throughout the procedure

summarizing the count and percentage of patients with unrecoverable shifts

Outcome measures

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=46 Participants 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.
Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts Map could be recovered	36 Participants
Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts Map could not be recovered	10 Participants

SECONDARY outcome

Timeframe: during procedure

Count and percentage of subjects in whom the mapping system was reported to be excellent, very good, good, poor and N/A

Outcome measures

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=503 Participants 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.
EnSite Precision™ Cardiac Mapping System Assessment Excellent	153 Participants
EnSite Precision™ Cardiac Mapping System Assessment Very Good	202 Participants
EnSite Precision™ Cardiac Mapping System Assessment Good	139 Participants
EnSite Precision™ Cardiac Mapping System Assessment Poor	8 Participants
EnSite Precision™ Cardiac Mapping System Assessment Not Applicable	1 Participants

SECONDARY outcome

Timeframe: during procedure

Population: 501 subjects had procedure time available

Overall procedure time summarized using mean and standard deviation

Outcome measures

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=501 Participants 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.
EnSite Precision™ Cardiac Mapping System Assessment	116.8 mins Standard Deviation 52.2

SECONDARY outcome

Timeframe: during procedure

Population: 117 subjects had gaps identified in the lesion line

Count and percentage of subjects where the AutoMark feature assisted in identifying gaps in lesion lines

Outcome measures

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=117 Participants 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.
Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement AutoMark assisted in identifying gaps	34 Participants
Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement AutoMark did not assist in identifying gaps	83 Participants

SECONDARY outcome

Timeframe: during procedure

Population: 373 procedures used AutoMark

Count and percentage of subjects where the AutoMark feature was easy to use

Outcome measures

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=373 Participants 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.
Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement AutoMark feature was easy to use	352 Participants
Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement AutoMark feature was not easy to use	4 Participants
Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement AutoMark Feature ease of use not available	17 Participants

Adverse Events

Subjects With EnSite Precision™ Cardiac Mapping

Serious events: 10 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=503 participants at risk 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.
Cardiac disorders Non-Sustained Ventricular Tachycardia	0.20% 1/503 • Number of events 1 • Adverse event data was collected from the beginning of the procedure through the Pre-discharge visit (maximum of 7 days after procedure). 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 investigational medical device under study. This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved.
Cardiac disorders Recurrence of Atrial Fibrillation	0.20% 1/503 • Number of events 1 • Adverse event data was collected from the beginning of the procedure through the Pre-discharge visit (maximum of 7 days after procedure). 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 investigational medical device under study. This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved.
Cardiac disorders Recurrent Arrhythmia	0.20% 1/503 • Number of events 1 • Adverse event data was collected from the beginning of the procedure through the Pre-discharge visit (maximum of 7 days after procedure). 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 investigational medical device under study. This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved.
Gastrointestinal disorders Esophageal Lesion	0.20% 1/503 • Number of events 1 • Adverse event data was collected from the beginning of the procedure through the Pre-discharge visit (maximum of 7 days after procedure). 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 investigational medical device under study. This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved.
Cardiac disorders Myocardial Infarction	0.20% 1/503 • Number of events 1 • Adverse event data was collected from the beginning of the procedure through the Pre-discharge visit (maximum of 7 days after procedure). 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 investigational medical device under study. This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	0.20% 1/503 • Number of events 1 • Adverse event data was collected from the beginning of the procedure through the Pre-discharge visit (maximum of 7 days after procedure). 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 investigational medical device under study. This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved.
Cardiac disorders Tachy-Brady Syndrome	0.20% 1/503 • Number of events 1 • Adverse event data was collected from the beginning of the procedure through the Pre-discharge visit (maximum of 7 days after procedure). 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 investigational medical device under study. This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved.
Cardiac disorders Pericardial Effusion	0.20% 1/503 • Number of events 1 • Adverse event data was collected from the beginning of the procedure through the Pre-discharge visit (maximum of 7 days after procedure). 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 investigational medical device under study. This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved.
Cardiac disorders Tamponade	0.40% 2/503 • Number of events 2 • Adverse event data was collected from the beginning of the procedure through the Pre-discharge visit (maximum of 7 days after procedure). 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 investigational medical device under study. This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved.

Other adverse events

Measure	Subjects With EnSite Precision™ Cardiac Mapping n=503 participants at risk 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.
Cardiac disorders Atrioventricular Nodal Reentrant Tachycardia	0.20% 1/503 • Number of events 1 • Adverse event data was collected from the beginning of the procedure through the Pre-discharge visit (maximum of 7 days after procedure). 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 investigational medical device under study. This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved.
Cardiac disorders Pericardial Effusion	0.20% 1/503 • Number of events 1 • Adverse event data was collected from the beginning of the procedure through the Pre-discharge visit (maximum of 7 days after procedure). 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 investigational medical device under study. This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved.

Additional Information

Clinical Research Scientist

Abbott

Phone: 6517562885

Email: amber.miller@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60