Model Based Fast Anatomical Mapping

Paroxysmal Atrial Fibrillation Clinical Trial

— MFAM  

Official title:

Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03349476
• Other study ID #: 17-02-329
• Status: Terminated
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: October 3, 2022

Study information

• Verified date: November 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 109
• Est. completion date: October 3, 2022
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Vivek Reddy	Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Fluoroscopy Time	Fluoroscopy (radiation) time for left atrial anatomy creation during the ablation procedure	hospital discharge, average 24 hours post procedure