EnSite Precision Observational Study

Completed

Conditions studied: Cardiac Arrhythmia

In brief

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™ Cardiac Mapping System (Software version 2.0.1 or higher) in a real-world environment. This study will be conducted in patients who are indicated for a cardiac electrophysiological (EP) mapping and radio frequency ablation procedure using a three-dimensional system.

Key facts

Study ID

NCT03260244

Run by

Abbott Medical Devices

People needed

1065

Starts

2017-09-12

Expected to finish

2020-03-31

Last updated by the study team

2024-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baptist Medical Center Princeton — Birmingham, Alabama, United States
• Cardiology Associates of North East Arkansas — Jonesboro, Arkansas, United States
• Arkansas Cardiology — Little Rock, Arkansas, United States
• Bethesda Memorial Hospital — Boynton Beach, Florida, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Bryan LGH Medical Center East — Lincoln, Nebraska, United States
• Aurora Medical Group — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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