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Model Based Fast Anatomical Mapping (MFAM)

Primary Purpose

Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MFAM

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Atrial Fibrillation, AFIB, Ablation, Paroxysmal, Persistent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MFAM

Arm Description

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.

Outcomes

Primary Outcome Measures

Accuracy of map

Accuracy of map (defined as the distance between the ablation points and the surface of the mFAM geometry)

Secondary Outcome Measures

Left atrial geometry creation time

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

Fluoroscopy amount

The amount of Fluoroscopy (radiation) used during the ablation procedure

Full Information

NCT ID

NCT03349476

First Posted

November 17, 2017

Last Updated

August 16, 2023

Sponsor

Vivek Reddy

Collaborators

Biosense Webster, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03349476

Brief Title

Model Based Fast Anatomical Mapping

Acronym

MFAM

Official Title

Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Terminated

Why Stopped

study closed prior to meeting enrollment goal due to difficulty enrolling.

Study Start Date

April 16, 2018 (Actual)

Primary Completion Date

October 3, 2022 (Actual)

Study Completion Date

October 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Vivek Reddy

Collaborators

Biosense Webster, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Keywords

Atrial Fibrillation, AFIB, Ablation, Paroxysmal, Persistent

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MFAM

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

MFAM

Intervention Description

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

Primary Outcome Measure Information:

Title

Accuracy of map

Description

Accuracy of map (defined as the distance between the ablation points and the surface of the mFAM geometry)

Time Frame

hospital discharge, average 24 hours post procedure

Secondary Outcome Measure Information:

Title

Left atrial geometry creation time

Description

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

Time Frame

hospital discharge, average 24 hours post procedure

Title

Fluoroscopy amount

Description

The amount of Fluoroscopy (radiation) used during the ablation procedure

Time Frame

hospital discharge, average 24 hours post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohit Turagam, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vivek Reddy, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Study Chair

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Model Based Fast Anatomical Mapping

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