Model Based Fast Anatomical Mapping

Vivek Reddy109 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

109

Conditions

Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation

Interventions

MFAMDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

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)

Time frame: hospital discharge, average 24 hours post procedure

Secondary Outcomes

Left Atrial Geometry Creation Time

The amount of time it takes to create the geometrical map using Carto and MFAM during the ablation procedure

Time frame: during the procedure up to 60 minutes

Fluoroscopy Time

Fluoroscopy (radiation) time for left atrial anatomy creation during the ablation procedure

Time frame: hospital discharge, average 24 hours post procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.