Status:
COMPLETED
EnSite Precision™ 2.0 Registry
Lead Sponsor:
Abbott Medical Devices
Conditions:
Cardiac Arrhythmias
Eligibility:
All Genders
18+ years
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 electrophys...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 15 2017
Estimated Enrollment :
515 Patients enrolled
Trial Details
Trial ID
NCT02757430
Start Date
August 30 2016
End Date
July 15 2017
Last Update
May 6 2019
Active Locations (1)
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1
Ospedale Cardinal Massaia di Asti
Asti, Italy, 14100