N/A
Completed N=515
EnSite Precision™ 2.0 Registry
Source: ClinicalTrials.gov NCT02757430 ↗Enrolled (actual)
515
Serious AEs
2.0%
Results posted
May 2019
Primary outcomePrimary: Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy — 461; 34; 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy |
461; 34; 8 | — |
| PRIMARY Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters |
14.2; 13.1; 6.6; 4.0 | — |
| PRIMARY Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping |
11.5; 20.0; 8.8; 18.3; 10.0; 3.6 | — |
| PRIMARY Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping |
14.3; 11.3; 10.1; 8.4; 6.0; 11.0 | — |
| PRIMARY Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping |
4.3; 17.0; 3.3; 8.0; 9.0 | — |
| PRIMARY Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters |
781.9; 954.5; 1127.3; 828.8; 612.3; 85.5 | — |
| PRIMARY Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability |
455; 46; 2 | — |
| PRIMARY Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts |
36; 10 | — |
| SECONDARY EnSite Precision™ Cardiac Mapping System Assessment |
116.8 | — |
| SECONDARY EnSite Precision™ Cardiac Mapping System Assessment |
116.8 | — |
| SECONDARY Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement |
352; 4; 17 | — |
| SECONDARY Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement |
352; 4; 17 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02757430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.