Model Based Fast Anatomical Mapping (MFAM)

Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping

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.

Study Overview

• Status: Terminated
• Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
• Intervention / Treatment: Device: MFAM

Detailed Description

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.

Specifically, the study will assess the following issues in atrial fibrillation ablation:

1. Accuracy of map (defined as the distance between the ablation points and the surface of the mFAM geometry)
2. Left atrial geometry creation time
3. Fluoroscopy time

The clinical team will hypothesize that this approach will lead to accurate LA geometry creation more rapidly and using less fluoroscopy than standard techniques

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years

• Have AF as follows:

  1. Paroxysmal AF - defined as AF that is non-sustained (terminate without electrical or pharmacologic cardioversion) lasting < 7 days.
  2. Persistent AF - defined as AF that is sustained > 7 days. Episodes of AF which are terminated by electrical or pharmacologic cardioversion after ≥ 48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes.
• Are planned to undergo a first catheter ablation procedure (prior typical atrial flutter is allowed)
• Have the ability to understand the requirements of the study and sign the informed consent form.
• Are willing to adhere to study restrictions and comply with all post-procedural follow-up requirements

Exclusion Criteria:

• Rheumatic heart disease,
• Current intra-cardiac thrombus
• Class IV HF
• Unable to sign consent
• Unstable angina
• Recent cerebral ischemic events
• Contradiction to anticoagulation
• Prior cardiac surgery
• Complex congenital heart disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MFAM; The mFAM Workstation is a computerized system used to reconstruct the shape of the left atrium of the heart, by fitting a parametric shape model to points data acquired by a catheter. The mFAM Workstation uses recorded catheter positions and other data inputs collected from various types of multi-electrode catheters and generates output data files that can be displayed as a 3D anatomic structure.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mMap Scoring Questionnaire	mMap Scoring Questionnaire: Tool used by operators to rate the accuracy of the map based on the distance between ablation points and accuracy of anatomy compared to the mapped mFam geometry. Total score from 1-7, with lower score indicating not representing (misleading) and higher score indicating agreement (accurate)	hospital discharge, average 24 hours post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluoroscopy Time	Fluoroscopy (radiation) time for left atrial anatomy creation during the ablation procedure	hospital discharge, average 24 hours post procedure
Left Atrial Geometry Creation Time	The amount of time it takes to create the geometrical map using Carto and MFAM during the ablation procedure	during the procedure up to 60 minutes

Collaborators and Investigators

• Sponsor: Vivek Reddy
• Collaborators: Biosense Webster, Inc.
• Investigators: Principal Investigator: Mohit Turagam, MD, Icahn School of Medicine at Mount Sinai; Study Chair: Vivek Reddy, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): October 3, 2022
• Study Completion (Actual): October 3, 2022

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Persistent; Ablation; Paroxysmal; AFIB
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 17-02-329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes