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EnSite Precision Observational Study

NCT03260244 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1065

Last updated 2024-11-08

Study results available
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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™ 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.

Conditions

  • Cardiac Arrhythmia

Interventions

PROCEDURE

cardiac mapping and radiofrequency ablation procedure

It is a minimally invasive procedure which can be performed using either general or conscious sedation. During catheter ablation, catheters (narrow, flexible tubes) are inserted into a blood vessel, often through a site in the groin (upper thigh) or neck, and guided through the vein until they reach the heart. Small electrodes on the tip of the catheters stimulate and record the heart's activity. This test, called an electrophysiology study (EPS), allows the doctor to pinpoint the exact location of the short circuit. Another word for pinpointing the exact location of the short circuit is 'mapping', for which precision is a key requirement to maximize a successful outcome. Once the location is confirmed, the short circuit is either destroyed (to reopen the electrical pathway) or blocked (to prevent it from sending faulty signals to the rest of the heart).

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Kristin Ruffner, PhD · Abbott

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2020-01-17
Completion
2020-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03260244 on ClinicalTrials.gov