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Model Based Fast Anatomical Mapping

NCT03349476 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2023-11-29

Study results available
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Summary

This prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation ablation.

Conditions

  • Paroxysmal Atrial Fibrillation
  • Persistent Atrial Fibrillation

Interventions

DEVICE

MFAM

Specifically, the mFAM Workstation accesses stored data of recorded electronic heart activity that has been obtained by conventional electrophysiological methods, using multi-electrode catheters placed in the heart (data inputs) for collection. Using proprietary software algorithms, the mFAM Workstation analyzes these data inputs and generates 3D anatomical structure. mFAM improves on the FAM functionality by applying a model-based approach for reconstruction of left atrial chamber anatomy

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Vivek Reddy

    lead OTHER

Principal Investigators

  • Mohit Turagam, MD · Icahn School of Medicine at Mount Sinai

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2022-10-03
Completion
2022-10-03
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 NCT03349476 on ClinicalTrials.gov