CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 515 enrolled
Drug / intervention
Cardiac Ablationprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02757430
NCT02757430N/ACompleted

EnSite Precision™ Cardiac Mapping System and EnSite Precision™ Software v2.0 Observational Registry

Abbott Medical Devices·observational·Posted May 2, 2016·Updated May 6, 2019

In Brief

An observational study evaluating Cardiac Ablation for Cardiac Arrhythmias. Completed, enrolled 515 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2, 2016
Enrollment StartAug 30, 2016
Primary CompletionJul 15, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.2 years ago

Interventions

Cardiac Ablationprocedure