Status:
COMPLETED
EnSite Precision Observational Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Cardiac Arrhythmia
Eligibility:
All Genders
18+ years
Brief Summary
This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study. This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Card...
Detailed Description
The EnSite Precision™ Cardiac Mapping System is a newly developed system that introduces features such as Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) image integration, lesion marking auto...
Eligibility Criteria
Inclusion
- Indicated for a cardiac electrophysiology mapping and radiofrequency ablation procedure using a 3-dimensional mapping system per Instructions for Use
- Over 18 years of age
- Able to provide informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule
Exclusion
- Patients who are only presenting with:
- Atrioventricular Nodal Reentrant Tachycardia (AVNRT)
- Atrioventricular Reentrant Tachycardia (AVRT)
- Planned cryoablation procedure
- Implanted with a neurostimulator
- Contraindication to anticoagulation
- Known presence of cardiac thrombus
- Recent (\<3 months) myocardial infarction or unstable angina or coronary artery by-pass
- Currently enrolled in a clinical study/investigation evaluating another device or drug that would confound the results of this study
- Pregnant or nursing
- Individuals whose willingness to volunteer in a study, in the judgement 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 :
September 12 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
1065 Patients enrolled
Trial Details
Trial ID
NCT03260244
Start Date
September 12 2017
End Date
March 31 2020
Last Update
November 8 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Baptist Medical Center Princeton
Birmingham, Alabama, United States, 35211
2
Cardiology Associates of North East Arkansas
Jonesboro, Arkansas, United States, 72401
3
Arkansas Cardiology
Little Rock, Arkansas, United States, 72205
4
Bethesda Memorial Hospital
Boynton Beach, Florida, United States, 33435