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RADAR Clinical Trial

NCT03263702 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2020-05-13

Study results available
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Summary

This prospective, multicenter, observational study will examine the ability of real time electrogram processing mapping to identify driver domains to target for ablation in persistent AF patients.

Conditions

  • Persistent Atrial Fibrillation

Interventions

DEVICE

Computational Mapping Algorithm

This software enables high resolution temporospatial mapping of atria for the identification of drivers of AF. CMA receives data from standard of care, commercially available 3D Mapping Systems (St. Jude Ensite System) and catheters and processes the data in a unique way. Electrogram and anatomy data are fed from the commercially available 3D Mapping System to an adjacent laptop computer, via an Ethernet connection, that is running CMA. CMA then processes the electrogram data and generates a map of where the potential AF driver domains are located and superimposes those potential AF driver domain targets onto the 3D geometry of the anatomy (provided by the 3D mapping system).

Sponsors & Collaborators

  • AFTx, Inc.

    collaborator INDUSTRY

  • Vivek Reddy

    lead OTHER

Principal Investigators

  • Vivek Reddy, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-26
Primary Completion
2019-06-07
Completion
2019-06-07
FDA Device
Yes

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 NCT03263702 on ClinicalTrials.gov