Model Based Fast Anatomical Mapping

Study Overview
=================
Brief 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.

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: Accuracy of map (defined as the distance between the ablation points and the surface of the mFAM geometry) Left atrial geometry creation time 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

Official Title
-----------------
Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping

Conditions
-----------------
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: MFAM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Have AF as follows: Paroxysmal AF - defined as AF that is non-sustained (terminate without electrical or pharmacologic cardioversion) lasting < 7 days. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MFAM<br>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<br>* 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<br>|

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 |
| --- | --- | --- |
| 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 | 
| Fluoroscopy Time | Fluoroscopy (radiation) time for left atrial anatomy creation during the ablation procedure | hospital discharge, average 24 hours post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, AFIB, Ablation, Paroxysmal, Persistent