NCT03349476

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

April 16, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 27, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

4.5 years

First QC Date

November 17, 2017

Results QC Date

October 3, 2023

Last Update Submit

November 7, 2023

Conditions

Paroxysmal Atrial FibrillationPersistent Atrial Fibrillation

Keywords

Atrial FibrillationAFIBAblationParoxysmalPersistent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Left Atrial Geometry Creation Time

    during the procedure up to 60 minutes

  • Fluoroscopy Time

    hospital discharge, average 24 hours post procedure

Study Arms (1)

MFAM

EXPERIMENTAL

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

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

MFAM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Stephanie Harcum
Organization
Icahn School of Medicine at Mount Sinai
stephanie.harcum@mountsinai.org
(212) 824-8927

Study Officials

  • Mohit Turagam, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Vivek Reddy, MD

    Icahn School of Medicine at Mount Sinai

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 21, 2017

Study Start

April 16, 2018

Primary Completion

October 3, 2022

Study Completion

October 3, 2022

Last Updated

November 29, 2023

Results First Posted

October 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)