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Clinical Utility and Validation of the Rhythmia Mapping System for the Treatment of Cardiac Arrhythmias

NCT03094221 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2017-03-29

No results posted yet for this study

Summary

The purpose of this study is to compare two different types of three-dimensional electroanatomic mapping systems used for the treatment of cardiac arrhythmias. The systems will be compared in regards to its ability to successfully map and ablate a clinical arrhythmia, as well as the time invested in this activity.

Conditions

Interventions

DEVICE

Rhythmia Mapping System

Arrhythmia mapping will be performed using the Rhythmia mapping system, including its mapping catheter, either in the atria or ventricles depending on the clinical arrhythmia being treated. Detailed mapping will be performed to determine tissue voltage and arrhythmia mechanism/location according to standard clinical practice. This part of the study will take approximately 90-120 minutes. The catheter position and contact will be visualized with intra-cardiac echocardiography, which is also routinely used during these procedures, and to monitor for potential clinically related complications. Images will be recorded to establish criteria for mapping.

Sponsors & Collaborators

Principal Investigators

  • Elad Anter, MD · Beth Israel Deaconess Medical Center, Harvard Medical School

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-13
Primary Completion
2015-12-01
Completion
2015-12-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT03094221 on ClinicalTrials.gov