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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Ablation | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy | summarizing the count and percentage of patients with accurate geometry | during procedure |
| 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™ | during procedure |
| 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 | during procedure |
| 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 | during procedure |
| 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 | during procedure |
| Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | during procedure |
| EnSite Precision™ Cardiac Mapping System Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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Any patient undergoing a cardiac EP mapping and ablation procedure, using the EnSite™ Precision Cardiac Mapping system, is considered eligible.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Cardinal Massaia di Asti | Asti | 14100 | Italy |
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Any patient indicated to undergo a cardiac electrophysiology (EP) mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System was considered eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy | summarizing the count and percentage of patients with accurate geometry | Posted | Count of Participants | Participants | during procedure |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Sustained Ventricular Tachycardia | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular Nodal Reentrant Tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Abbott | 6517562885 | amber.miller@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 25, 2019 | Jan 25, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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mapping points collected and used will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) |
| during procedure |
| Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability | summarizing the count and percentage of patients with overall system stability | during procedure |
| Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts | summarizing the count and percentage of patients with unrecoverable shifts | during procedure |
Overall procedure time summarized using mean and standard deviation
| during procedure |
| 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 | during procedure |
| 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 | during procedure |
| No procedure performed |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Ejection Fraction | 'Abnormal' and 'Normal' ejection fraction defined by physician/Standard Practice | Count of Participants | Participants |
|
| Ejection Fraction | Ejection Fraction provided when evaluated and considered by physician to be abnormal. | Mean | Standard Deviation | % |
|
| NYHA Heart Failure Classification | New York Heart Association (NYHA) functional classifications are used to classify severity of patient heart failure by placing patients in one of four categories based on how much they are limited during physical activity. Class I is no limitation of physical activity. Class IV is unable to carry on any physical activity without discomfort. | Count of Participants | Participants |
|
| Left Atrial Diameter | Left Atrial Diameter provided when evaluated and considered by physician to be abnormal | Mean | Standard Deviation | mm |
|
| Left Atrial Volume | Left Atrial Volume provided when evaluated and considered by physician to be abnormal | Mean | Standard Deviation | ml |
|
| Indication for Procedure | Count of Participants | 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™ | 603 total maps were created in 421 subjects. | Posted | Mean | Standard Deviation | min | during procedure | maps | maps |
|
|
|
| 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 | 62 total Manual maps were created. | Posted | Mean | Standard Deviation | min | during procedure | manual maps | manual maps |
|
|
|
| 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 | 526 total AutoMap Module maps were created. | Posted | Mean | Standard Deviation | min | during procedure | AutoMap Module Maps | AutoMap Module Maps |
|
|
|
| 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 | 13 total TurboMap Module maps were created. | Posted | Mean | Standard Deviation | min | during procedure | TurboMap Module Maps | TurboMap Module Maps |
|
|
|
| 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) | 606 total maps with mapping points collected available were created in 421 subjects. | Posted | Mean | Standard Deviation | mapping points collected | during procedure | maps | maps |
|
|
|
| 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) | 606 total maps with mapping points used available were created in 421 subjects. | Posted | Mean | Standard Deviation | mapping points used | during procedure | maps | maps |
|
|
|
| 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 | Posted | Count of Participants | Participants | during procedure |
|
|
|
| Primary | Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts | summarizing the count and percentage of patients with unrecoverable shifts | 46 procedures with system not stable throughout the procedure | Posted | Count of Participants | Participants | during procedure |
|
|
|
| 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 | Posted | Count of Participants | Participants | during procedure |
|
|
|
| Secondary | EnSite Precision™ Cardiac Mapping System Assessment | Overall procedure time summarized using mean and standard deviation | 501 subjects had procedure time available | Posted | Mean | Standard Deviation | mins | during procedure |
|
|
|
| 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 | 117 subjects had gaps identified in the lesion line | Posted | Count of Participants | Participants | during procedure |
|
|
|
| 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 | 373 procedures used AutoMark | Posted | Count of Participants | Participants | during procedure |
|
|
|
| 0 |
| 503 |
| 10 |
| 503 |
| 2 |
| 503 |
| Recurrence of Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Recurrent Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Esophageal Lesion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Tachy-Brady Syndrome | Cardiac disorders | Non-systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | Non-systematic Assessment |
|
| Tamponade | Cardiac disorders | Non-systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | Non-systematic Assessment |
|
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| D013514 |
| Surgical Procedures, Operative |
| AutoMap |
|
|
| TurboMap |
|
|
| Other |
|
|
| Atrial Fibrillation |
|
|
| Atrial Flutter |
|
|
| Atrial Tachycardia |
|
|
| Atrioventricular Reentry Tachycardia |
|
|
| Atrioventricular Nodal Reentry Tachycardia |
|
|
| Ventricular Tachycardia |
|
|
| Other |
|
|
| Atrial Fibrillation |
|
|
| Atrial Flutter |
|
|
| Atrial Tachycardia |
|
|
| Atrioventricular Reentry Tachycardia |
|
|
| Atrioventricular Nodal Reentry Tachycardia |
|
|
| Ventricular Tachycardia |
|
|
| Other |
|
|
| Atrial Fibrillation |
|
|
| Atrial Flutter |
|
|
| Atrial Tachycardia |
|
|
| Other |
|
|
| Sinus Rhythm |
|
|
| Atrial Fibrillation |
|
|
| Atrial Flutter |
|
|
| Atrial Tachycardia |
|
|
| Atrioventricular Reentry Tachycardia |
|
|
| Arioventricular Nodal Reentry Tachycardia |
|
|
| Ventricular Tachycardia |
|
|
| Other |
|
|
| Sinus Rhythm |
|
|
| Atrial Fibrillation |
|
|
| Atrial Flutter |
|
|
| Atrial Tachycardia |
|
|
| Atrioventricular Reentry Tachycardia |
|
|
| Arioventricular Nodal Reentry Tachycardia |
|
|
| Ventricular Tachycardia |
|
|
| Other |
|
|
| Poor |
|
| Not Applicable |
|