NCT03260244

EnSite Precision Observational Study

A Clinical Evaluation Using EnSite Precision Cardiac Mapping System (Software Version 2.0.1 or Higher) in a Real-World Environment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,065 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 automaticity, automatic mapping, and workflow flexibility to aid in the success of complex ablation procedures. Utilization of this system in the treatment of complex ablation procedures and its impact on patient outcomes is not well characterized. This clinical study is designed to collect a broad range of usage scenarios, therefore this clinical study has limited patient selection criteria and data collection is focused on EnSite Precision™ Cardiac Mapping System usage and patient outcomes. The data collected from the procedure (performed per Instructions For Use (IFU) and per standard practice of the physician) as well as the 12 month follow up period enables the Sponsor to review the system's standard practice usage. This information will be added to the current knowledge and understanding of treatment options for patients with arrhythmias, which can assist the Sponsor to provide future recommendations for best practices to improve patient outcomes.

Conditions

• Cardiac Arrhythmia

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-09-12
• Primary completion: 2020-01-17
• Completion: 2020-03-31
• First posted: 2017-08-24
• Last updated: 2024-11-08
• Results posted: 2024-11-08

Locations

7 sites across 1 country: United States